The symptomatic (swelling and pain) salivary gland obstructions are caused by sialolithiasis and salivary duct stenosis, negatively affecting quality of life (QOL), with almost all candidates for clinical measures and minimally invasive sialendoscopy. The impact of sialendoscopy treatment on the QOL has been little addressed nowadays. The objective is to prospectively evaluate the impact of sialendoscopy on the quality of life of patients undergoing sialendoscopy due to benign salivary obstructive diseases, measured through QOL questionnaires of xerostomia degree, the oral health impact profile and post sialendoscopy satisfaction questionnaires.
Result
37 sialendoscopies were included, most young female; there were 64.5% sialolithiasis and 35.4% post-radioiodine; with 4.5 times/week painful swelling symptoms and 23.5 months symptom duration. The pre- and post-sialendoscopy VAS values were: 7.42 to 1.29 (p < 0.001); 86.5% and 89.2% were subjected to sialendoscopy alone and endoscopic dilatation respectively; 80.6% reported improved symptoms after sialendoscopy in the sialolithiasis clinic (p < 0.001). The physical pain and psychological discomfort domain scores were mostly impacted where sialendoscopy provided relief and improvement (p < 0.001). We found a positive correlation between sialendoscopy and obstructive stone disease (p < 0.001) and no correlation in sialendoscopy satisfaction in xerostomia patients (p = 0.009).
Conclusions
We found improved symptoms with overall good satisfaction after sialendoscopy correlated with stones; and a negative correlation between xerostomia. Our findings support the evident indication of sialendoscopy for obstructive sialolithiasis with a positive impact on QOL and probably a relative time-dependent indication for stenosis/other xerostomia causes that little improved QOL satisfaction.
Level of evidence
2b—Prospective non-randomized study.
Trial registration: WHO Universal Trial Number (UTN): U1111-1247-7028; Brazilian Clinical Trials Registry (ReBeC): RBR-6p8zfs.
Hinweise
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Abkürzungen
QOL
Quality of life questionnaire
XER
Xerostomia degree questionnaire
OHIP
Oral health impact profile questionnaire
QoL
Quality of life questionnaires
CAAE
Institutional Ethics Committee
WHO
World Health Organization
UTN
Universal trial number
ReBec
Brazilian Clinical Trials Registry
PROCESS
Preferred reporting of case series in surgery
STROCSS
Strengthening the reporting of cohort studies in surgery
SQUIRE 2.0
Standards for Quality Improvement Reporting Excellence guidelines
VAS
Visual pain analog scale
Pre-VAS
Pre-sialendoscopy visual pain analog scale score
Post-VAS
Post-sialendoscopy visual pain analog scale score
PSPS
Questionnaire on patient satisfaction post-sialendoscopy
USG
Ultrasonography
Introduction
The symptomatic obstructions of major salivary duct are primarily caused by sialolithiasis (50–75%) and salivary duct stenosis (25%) [1]; however, the annual incidence in the world can vary widely among the countries, oscillating from 1/10,000–30,000 hab. to 27–59/1,000,000 hab. [2, 3].
The etiology of obstructive sialadenitis can vary, including salivary stones, stenosis, protein plugs, anatomic variations or deformations, actinic, and autoimmune, all of which lead to salivary flow obstruction with increasing intraductal salivary pressure, swelling of the gland, and pain. It can be symptomatic, occurring mainly during meals, with a mean duration of 24–48 h, and the pain negatively affecting quality of life (QOL). Sometimes the clinical state can worsen with infection, purulent discharge, and phlogistic signals, requiring antibiotics, corticoids, anti-inflammatory drugs, fasting, and other clinical measures [1, 2, 4‐8].
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Anatomic variations of Wharton’s duct of the submandibular gland and saliva composition alterations play important roles in increasing the stasis of salivary flow with mucous plug and stone formation with obstructive sialolithiasis (80–90%). The parotid gland is mainly affected by salivary duct stenosis, occurring in nearly 69% of cases. It is associated with Sjögren’s disease and the radioiodine treatment of thyroid cancer [5, 9, 10]. In addition, stenosis is present in approximately 25% of all benign obstructive sialodenitis cases, caused by periductal tissue fibrosis, duct angulations, and duct gauge decrease, occurring in one or more points along the duct tree [5, 11].
The majority of obstructive salivary patients are candidates for clinical measures and endoscopic gland procedure management, because once the obstruction is removed, the gland’s function is maintained. This has been successfully achieved by minimally invasive techniques like sialendoscopy, introduced in the 1990’s for the diagnosis and treatment of salivary duct diseases. Its efficacy and utility have been proven among several authors along the years [2, 12‐19]. The technique introduces a miniaturized sialendoscope (1.3 to 1.7 mm) into the opening papilla of the salivary duct, either submandibular or parotid, to inspect, clean, dilate, remove stones and infuse successfully intraglandular duct corticoids, which are utilized in nearly all benign obstructive causes [12, 14, 17, 20‐28].
The quality of life during the periods of obstructive sialadenitis has been poor evaluated, with some authors demonstrating a dramatic worsening due intense face and cervical pain, feeding difficulties, weight loss, tooth and salivary problems and decreased self-care [29, 30]. Using questionnaires, the quality of life (QOL), xerostomia degree (XER) and the oral health impact profile (OHIP) has long been used to evaluate the quality of treatment in majority of head and neck cancer patients and the present authors used these previously cited to specifically evaluate the sialendoscopy treatment at the moment, although recently other papers have used different ones and some need to be worldwide validated [29‐35].
The objective is to prospectively evaluate the impact of sialendoscopy on the quality of life of patients undergoing sialendoscopy due to benign obstructive diseases of the salivary glands, measured through QoL questionnaires.
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It will enable us to measure the patient overall satisfaction before and after procedure; and thus, the impact of the sialendoscopy treatment, enhancing its usefulness to most centers worldwide. We hope that our results can improve the ability of assistant physician and the health system managers in better-selecting patients for sialendoscopy.
Methods
This was a prospective, non-randomized, case series, cohort observational study, without biospecimen retention, unicentric with consecutive benign salivary gland obstructive disease patients. They were admitted and treated with sialendoscopy alone, or in combination, with a minimal cervical approach at the Department of Head and Neck Surgery between January 2017 and January 2020, with a minimum follow-up of 6 months. The inclusion criteria were as follows: consecutive patients who had undergone sialendoscopy by the same surgical team, with or without combined open facial/cervical preservative gland access as initial treatment for benign obstructive salivary gland disease; patients who agreed to participate in the study; patients who filled the formularies; and patients with indications for endoscopic treatment of salivary gland disease. The exclusion criteria included patients who were exclusively indicated for open surgery, had no indication for sialendoscopy, failed to undergo sialendoscopy during the surgical procedure, missed follow-ups, refused to complete the questionnaire or participate, had missing records, abandoned treatment prior to completion, and had previous surgery on that salivary gland or previous neck radiotherapy, due to another head and neck neoplasia.
The present study was only based on clinical data and the resulting questionnaires, without any further surgical intervention. All patients who agreed to participate in the study have written and signed the ethics approval and informed consent statement. This study was approved by the Institutional Ethics Committee (CAAE: 95881418.2.0000.5483, number 2.934.247) in October 2018.
The study was conducted in accordance with the Declaration of Helsinki and registered with the WHO Universal Trial Number (UTN) number (U1111-1247-7028) and the Brazilian Clinical Trials Registry (ReBeC), whose number is RBR-6p8zfs. This study is in accordance with the Preferred Reporting of Case Series in Surgery (PROCESS) criteria [36], Strengthening the Reporting of Cohort Studies in Surgery (STROCSS) [37] and the Standards for Quality Improvement Reporting Excellence guidelines (SQUIRE 2.0) [38].
Study design
All eligible consecutive patients with benign salivary gland obstructive disease patients who will be treated with sialendoscopy alone (or in possible combination with a minimal cervical approach as necessary), after provided their consent to participate in the study, were given the QOL questionnaires and the visual pain analog scale (VAS) just before the procedure; and again after 2 months prospectively after sialendoscopy procedure, where they were called by phone, filled out the forms and brought them to follow-up consultations.
Questionnaires
The QOL questionnaires applied were as follows:
The OHIP questionnaire—the oral health impact profile, as validated to Brazilian portuguese language, [39‐41] with 49 questions on seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap; that measures people's perceptions of the impact of oral conditions on their well-being. Responses from the patients were made on a Likert-type scale, coded as: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often and 4 = very often; the descriptive statistics were created by computing the mean of each coded response.
The Xerostomia (Xer) questionnaire, also validated in Brazilian Portuguese language [31, 42, 43] with 21 questions covering the symptomatic obstructive, hyposalivation and inflammatory salivary pathologies related to salivary gland dysfunction. The patient has to score from 1 to 5 each condition, according to the severity, so a higher score correspond to an increased complaint.
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The questionnaire on patient satisfaction post-sialendoscopy (PSPS) [30] was created based on the existing quality of life surveys, with 14 questions covering the main afflictions before and after the sialendoscopy procedure and the overall satisfaction. This survey included dichotomous response choices and ten-level response choice, scaled from 1 to 10.
The visual pain analog scale (VAS) [44] for pain analysis, consisting of a straight line with the endpoints defining the limits, with “no pain at all” and “pain bad as could be”; the scale is numerically rated from 0 to 10 and the patients are asked to circle the number from 1 to 10 or the face figure drawing corresponding to the symptoms.
Clinical and demographic data, sialendoscopy diagnostic and intervention data results, and data from the questionnaires (OHIP, Xer, and PSPS) were collected. Follow-up was performed with regular consultations, one week after post-operatory procedures and then at 30, 60, and 90 days, with a salivary gland ultrasonography (USG) at 90 days in all patients.
All data were collected and the statistical analyses were performed using the Spearman’s correlation test, Mann–Whitney test, two-proportions equality test, Wilcoxon test, and chi-square test, with a significance of p < 0.05.
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Sialendoscopy protocol
Sialendoscopy was performed by the same surgeon (GMM) and surgical team, following the Marchal et al. standards [14] in the operating room, in-hospital, and under general anesthesia. It was performed on the involved gland for both diagnostic and therapeutic interventions, using the semi-rigid modular sialendoscope (Karl Storz, Tuttlingen, Germany) (diameter 1.3 mm or 1.7 mm), with working channel, salivary probes, conic dilatators, bougies, baskets for stones, dilatator balloons, silastic stents to the main duct, and papilla patency [27] (Figs. 1, 2). No case with acute purulent salivary discharge and sialadenitis were submitted to the procedure.
Fig. 1
Final image stone sequence. A Obstructive sialolithiasis in the main duct. B Basket in position beside the stone. C Open basket holding the stone. D Exteriorizing the set through the mouth. E Sialolithiasis measuring 4 mm
Fig. 2
Final image stenosis sequence. A Severe Stenosis with pale intraductal mucosa. B Dilatator Balloon in position, inside the stenosis. C Inflated Balloon, one can see the light reflect in the balloon filled with water. D Severe turned in mild Stenosis improving the saliva flow
×
×
In cases of minimal open access, a 2–3 cm skin incision was made in the appropriate skin crease. Minimal surgical dissection techniques were achieved with facial nerve monitoring; the main duct was opened and the impacted stone was removed. All cases were subjected to intraductal steroids delivered with the sialendoscope, main duct and papilla stenting with silicone, and were withdrawn after 21 days. All patients remained in-hospital for at least 24 h and were discharged to ambulatory follow-up.
Results
During this period of three years, 40 patients underwent sialendoscopy. Five refused to participate and four missed follow-up appointments. The final cohort included 37 sialendoscopies in 31 patients. All patients underwent preoperative examinations with at least salivary gland ultrasound, computed tomography (CT), and magnetic resonance imaging.
Clinical data
The population was comprised of 17 females and 14 males with a mean age of 44.7 years (11–80 years) and follow-up of 14 months (6–38 months). Clinical characteristics are shown in Table 1. Frequent comorbidities included hypertension (29.0%), previous radioiodine treatment (16.1%), and 19.35% high-volume milk ingestion (> 1.000 mL/day). No case with acute purulent salivary discharge and sialadenitis were submitted to the procedure.
Table 1
Clinical and symptoms characteristics
Clinical characteristics
N
Percent
31
100%
Gender
Male
14
45.20%
Female
17
54.80%
Age (years) (average/ range)
44.7
Nov-80
Follow-up (months) (average/ range)
14
Jun-26
Comorbidities
Hypertension
9
29.00%
Diabetes mellitus
2
3.20%
Auto-immune diseases
2
6.45%
Thyroid cancer with RIT
5
16.10%
Tobacco smoker
2
6.45%
High volume milk ingestion
6
19.35%
Antidepressant medication
2
6.45%
Time to diagnosis at first consultation (months)
23.2
1–168
(average/range)
Symptoms characteristics before procedure (more than one)
Swellings
30
96,8%
Pain
28
90.30%
Pus in the oral cavity
6
19.35%
Sialolithiasis perception
18
58.00%
Salivation changes
14
45.20%
Dry mouth
10
32.20%
Time of symptoms duration (months) (average, range)
23.5
1–168
Complaints per week (average, range)
4.5
Jan-14
Pre-operatory pain (VAS 0–10)
7.4
01-Oct
(average/ range)
Gland involved
Parotid
10
32.30%
Submandibular
21
67.70%
Sublingual
0
0%
Side
Right
17
54.80%
Left
8
25.80%
Bilateral
6
19.40%
Etiology (some bilateral)
Pure stones
16
51.60%
Stenosis (radioiodine/inflammatory)
13
41.90%
Stenosis + stones
4
12.90%
Radiological pre-operatory exam
Ultrasound (USG)
30
96.70%
Tomography (CT)
18
58.10%
Resonance (MR)
14
45.20%
Scintigraphy
5
16.10%
Size stones on USG (mm) (average/ range)
3.77
Feb-15
VAS pain Visual Analogic Scale
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Swelling (96.8%) and pain (90.3%) were the most frequent symptoms, with an average complaint rate of 4.5 times per week, pre-pain VAS average of 7.42 (1–10), delay of 21.7 months from first symptom to medical diagnosis, and symptom duration of 23.5 months (1–168 months). No patients required resection surgery (Table 1). The involved glands were the submandibular (67.7%) and parotid (32.3%), right side (54.8%) and bilateral in 19.4% of cases. The etiology was as follows: stones, 51.6%; stenosis, 41.9%; preoperative USG, 96.7%; CT, 58.1%. The average intraductal stone size on USG was 3.77 mm (2–15 mm).
Clinical characteristics of sialendoscopy
Table 2 shows the sialendoscopy findings, 86.5% were subjected to sialendoscopy alone, 89.2% to endoscopic dilatation, and 100% to intraductal steroids. The percentages according to diagnoses were as follows: 48.6% submandibular stone, 40.5% pure stones, and 32.4% papilla stenosis. The most common papilla type was type A (48.6%). Stenting (papilla or duct, once it is difficult to only stent the papilla site): 100% and dilatation (35.1%) were the most common procedures. The stones were single in 37.8% of cases, overall complications were 10.8%, average time of sialendoscopy was 139.5 min, and the postoperative pain score was 1.3. All patients submitted to the combined-hybrid procedure have answered the questionnaires with the main objective of evaluating the role of sialendoscopy associated or not with the combined procedure.
Table 2
Sialendoscopy clinical characteristics
Sialendoscopy clinical characteristics
N
Percent
37
100%
Sialendoscopy alone
32
86.50%
Combined sialendoscopy
5
13.50%
Sialendoscopy procedures (more than one)
Endoscopic stone extraction
20
54.10%
Endoscopic dilatation
33
89.20%
Intraductal stenting
30
81.10%
Intraductal steroids
37
100%
Sialendoscopy diagnosis verified (more than one)
Pure stones
15
40.50%
Parotid stones
3
8.10%
Submandibular stones
18
48.60%
Stones and stenosis
4
10.80%
Papilla stenosis
12
32.40%
Parotid duct stenosis
9
24.30%
Submandibular duct stenosis
5
13.50%
Papilla types
A
18
48.60%
B
7
18.90%
C
2
5.40%
D
4
10.80%
E
6
16.20%
Procedures on papilla (more than one)
Papillotomy
10
27.00%
Dilatation
13
35.10%
Opening floor of mouth
10
27.00%
Marsupialization
12
32.40%
Stenting
37
100%
Stones characteristics
Single
14
37.80%
Multiple
6
16.20%
Post-operative complications
Lost stent
4
10.80%
Infection
0
0%
Dehiscence
0
0%
Endoscopic duct classification LSD
L0
16
43.20%
L1
12
32.40%
L2
4
10.80%
L3
5
13.50%
S0
17
45.90%
S1
13
35.10%
S2
3
8.10%
S3
3
8.10%
S4
1
2.70%
D0
17
45.90%
D1
11
29.70%
D2
9
24.30%
D3
0
0%
Complications
4
10.80%
Sialendoscopy time duration (min)
(average, range)
139.5
80–210
Post-operatory Pain (VAS 0–10)
(average/ range)
1.3
0–3
Bold values indicate the findings of statistical significance
LSD lithiasis, stenosis and dilatation endoscopic classification, VAS pain Visual Analogic Scale
In our findings, the most important question on the PSPS questionnaire, given after the procedure, was number 7 (Sialo7), which indicated the overall satisfaction of the patient with sialendoscopy, the other questions were equal to prior questionnaires; we coded the answers with numbers 1 to 4: Bad (1), Satisfactory (2), Good (3), and Very Good (4). The average was 3.45, indicating that the majority of patients expressed Very Good/Good satisfaction with sialendoscopy. We compared all the other questionnaires with the answer Sialo7.
Oral health impact profile (OHIP) and Xerostomia (Xer) questionnaires
The overall OHIP punctuation was 32.52 ± 10.82 (196 total points). The Xer questionnaire, the overall average was 24.65 ± 7.06 (105 total points).
Table 3 demonstrates the frequency of qualitative clinical data, showing statistical differences in diabetes mellitus, hypertension, autoimmune diseases, high milk ingestion, tobacco, submandibular and parotid gland, on-bulking, dry mouth, salivary lithiasis, salivary changes, and right side. For the Sialo7 question, 80.6% were Very Good/Good versus 19.4% Satisfactory/Bad (p < 0.001).
Table 3
Frequency distribution of qualitative clinical data
N
%
P-valor
Comorbidities
No
16
51.6
0.799
Yes
15
48.4
DM
No
28
93.3
< 0.001
Yes
2
6.7
Autoimmune disease
No
28
93.3
< 0.001
Yes
2
6.7
Actual salivary gland: parotid
No
21
67.7
0.005
Yes
10
32.3
Actual salivary gland: submand
No
10
32.3
0.005
Yes
21
67.7
Hypertension
No
21
70.0
0.002
Yes
9
30.0
Milk ingestion
No
23
79.3
< 0.001
Yes
6
20.7
Other
No
22
78.6
< 0.001
Yes
6
21.4
Gender
Female
18
58.1
0.204
Male
13
41.9
Sialo 7
Very/Good
25
80.6
< 0.001
Satisf./Bad
6
19.4
Tobacco use
No
28
96.6
< 0.001
Yes
1
3.4
Symptom: swelling
No
1
3.2
< 0.001
Yes
30
96.8
Symptom: dry mouth
No
21
67.7
0.005
Yes
10
32.3
Symptom: salivary stone
No
11
35.5
0.022
Yes
20
64.5
Symptom: saliva changes
Não
15
48,4%
0.799
Sim
16
51,6%
Compromised side
Bilateral
6
19.4
0.004
Rigth
17
54.8
Ref
Left
8
25.8
0.020
Bold values indicate the findings of statistical significance
DM diabetes mellitus
Sialo 7: question 7 in the Patient satisfaction post-sialendoscopy questionnaire—(PSPS questionnaire) meaning the overall satisfaction of the patient with sialendoscopy
Table 4 shows Spearman’s correlation for the Sialo7 question (major satisfaction), relating satisfaction with the sialendoscopy procedure to the variables mentioned. When positive, the correlated variables increased proportionally; however, when the correlation was negative, it implied that the variables were inversely proportional.
Table 4
Correlation of PSPS (question Sialo 7) with ordinal and quantitative variables
Sialo (Q7)
Corr (r)
P-valor
Demographics
Age
− 0.293
0.110
Time to diagnosis
− 0.210
0.257
Symptoms time
− 0.165
0.376
Pre VAS
− 0.194
0.296
Symptoms frequency
0.170
0.360
USG stone size
0.357
0.049
Functional limitation
Q1
− 0.040
0.830
Q2
− 0.140
0.451
Q3
− 0.376
0.037
Q4
− 0.032
0.865
Q5
− 0.303
0.097
Q6
− 0.218
0.238
Q7
0.048
0.797
Q8
− 0.042
0.823
Q17
− 0.296
0.106
Functional limitation
− 0.080
0.669
Physical pain
Q9
− 0.167
0.369
Q10
0.124
0.505
Q11
0.113
0.544
Q12
− 0.134
0.474
Q13
− 0.201
0.278
Q14
− 0.015
0.936
Q15
0.094
0.613
Q16
− 0.152
0.413
Q18
− 0.349
0.055
Physical pain
0.107
0.567
Psychological discomfort
Q19
− 0.188
0.311
Q20
− 0.188
0.311
Q21
− 0.605
< 0.001
Q22
0.009
0.964
Q23
− 0.093
0.618
Psychological discomfort
− 0.235
0.204
Physical disability
Q24
− 0.269
0.143
Q25
− 0.398
0.026
Q26
− 0.119
0.523
Q27
− 0.099
0.598
Q28
0.104
0.577
Q29
0.043
0.818
Q30
− 0.349
0.055
Q31
− 0.271
0.140
Q32
0.006
0.973
Physical disability
− 0.081
0.666
Psychological disability
Q33
− 0.159
0.392
Q34
− 0.118
0.528
Q35
− 0.203
0.274
Q36
− 0.389
0.031
Q37
− 0.102
0.586
Q38
0.010
0.959
Psychological disability
− 0.089
0.634
Social disability
Q39
− 0.162
0.385
Q40
− 0.073
0.698
Q41
− 0.324
0.075
Q42
− 0.206
0.266
Q43
− 0.134
0.472
Social disability
− 0.123
0.508
Handicap
Q44
− 0.287
0.118
Q45
− 0.478
0.006
Q46
− 0.660
< 0.001
Q47
− 0.441
0.013
Q48
− 0.349
0.055
Q49
− 0.296
0.106
Handicap
− 0.465
0.008
Total OHIP
− 0.111
0.554
Xerostomia
P1
0.004
0.985
P2
0.046
0.805
P3
− 0.188
0.312
P4
− 0.306
0.094
P5
− 0.403
0.025
P6
− 0.388
0.031
P7
− 0.301
0.100
P8
− 0.254
0.169
P9
− 0.310
0.090
P10
− 0.364
0.044
P11
− 0.283
0.123
P12
− 0.244
0.186
P13
− 0.274
0.135
P14
− 0.390
0.030
P15
− 0.443
0.013
P16
− 0.242
0.189
P17
− 0.334
0.066
P18
− 0.509
0.003
P19
− 0.203
0.272
P20
− 0.259
0.159
P21
− 0.301
0.100
Total
− 0.284
0.122
Bold values indicate the findings of statistical significance
Sialo 7: question 7 in the Patient satisfaction post-sialendoscopy questionnaire—(PSPS questionnaire) meaning the overall satisfaction of the patient with sialendoscopy
OHIP oral health impact profile questionnaire, Xerostomia Xerostomia (Xer) questionnaires
We found a positive correlation between sialendoscopy and calculi size: the amount of sialolithiasis associated with better sialendoscopy satisfaction results. The best correlation was with question 46 of OHIP, which showed that the higher the Sialo7 (the greater the satisfaction), the lower the question 46 score, which was classified as Very Good.
Table 5 demonstrates the grouped answers of Sialo7 in Very Good/Good and Satisfying/Bad in the Mann–Whitney test to compare the quantitative variables in the various groups. There were differences in the OHIP: question 17 (p = 0.041), question 45 (p = 0.014), question 46 (p = 0.002), and Xer total score (p = 0.009). These results showed no correlation in sialendoscopy satisfaction in xerostomia patients, where the mean of Satisfying/Bad was 46.5 versus 19.4 Very Good/Good answers (p = 0.009).
Table 5
Comparison of the PSPS (question 7) with ordinal and quantitative variables and to the oral health impact profile (OHIP) and Xerostomia (Xer) questionnaires
Average
Median
Standard deviation
N
IC
P-valor
Age
Satisf./Bad
50.8
53.5
12.4
6
9.9
0.202
Very/Good
43.3
40
16.2
25
6.3
Time to diagnosis
Satisf./Bad
30.8
13
49.7
6
39.8
0.192
Very/Good
19.6
8
38.0
25
14.9
Symptoms time
Satisf./Bad
20.5
19.5
7.8
6
6.2
0.260
Very/Good
24.3
12
36.6
25
14.3
Pre VAS
Satisf./Bad
8.00
8
1.90
6
1.52
0.446
Very/Good
7.28
7
2.09
25
0.82
Symptoms frequency
Satisf./Bad
4.17
3
2.23
6
1.78
0.879
Very/Good
4.60
4
3.21
25
1.26
USG stone size
Satisf./Bad
1.67
0
3.20
6
2.56
0.089
Very/Good
4.28
4
4.15
25
1.63
Q1
Satisf./Bad
1.00
0.5
1.26
6
1.01
0.826
Very/Good
0.92
0
1.26
25
0.49
Q2
Satisf./Bad
0.17
0
0.41
6
0.33
0.534
Very/Good
0.36
0
0.64
25
0.25
Q3
Satisf./Bad
0.50
0
0.84
6
0.67
0.274
Very/Good
0.36
0
1.11
25
0.44
Q4
Satisf./Bad
0.83
0,5
0.98
6
0,79
0.596
Very/Good
0.68
0
1.07
25
0,42
Q5
Satisf./Mal
0.33
0
0.82
6
0.65
0.731
Very/Good
0.20
0
0.58
25
0.23
Q6
Satisf./Bad
1.00
0
1.67
6
1.34
0.277
Very/Good
0.32
0
0.80
25
0.31
Q7
Satisf./Bad
0.50
0
1.22
6
0.98
0.785
Very/Good
0.56
0
1.12
25
0.44
Q8
Satisf./Bad
0.83
0
1.33
6
1.06
0.595
Very/Good
0.44
0
0.82
25
0.32
Q17
Satisf./Bad
0.33
0
0.82
6
0.65
0.041
Very/Good
0.00
0
0.00
25
- x -
Functional limitation
Satisf./Bad
5.50
2
7.84
6
6.27
0.980
Very/Good
3.84
2
3.91
25
1.53
Q9
Satisf./Bad
1.33
0
2.07
6
1.65
0.630
Very/Good
0.68
0
1.18
25
0.46
Q10
Satisf./Bad
1.17
0.5
1.60
6
1.28
0.562
Very/Good
1.56
2
1.45
25
0.57
Q11
Satisf./Bad
0.67
0
1.63
6
1.31
0.271
Very/Good
0.88
1
1.01
25
0.40
Q12
Satisf./Bad
0.67
0
1.63
6
1.31
0.971
Very/Good
0.52
0
1.16
25
0.45
Q13
Satisf./Bad
0.50
0
1.22
6
0.98
0.876
Very/Good
0.24
0
0.66
25
0.26
Q14
Satisf./Bad
0.50
0
1.22
6
0.98
0.696
Very/Good
0.48
0
0.92
25
0.36
Q15
Satisf./Bad
1.33
0.5
1.75
6
1.40
0.671
Very/Good
1.76
2
1.71
25
0.67
Q16
Satisf./Bad
0.50
0
1.22
6
0.98
0.672
Very/Good
0.64
0
1.25
25
0.49
Q18
Satisf./Bad
0.50
0
1.22
6
0.98
0.240
Very/Good
0.04
0
0.20
25
0.08
Physical pain
Satisf./Bad
7.17
1
12.66
6
10.13
0.248
Very/Good
6.80
6
5.93
25
2.32
Q19
Satisf./Bad
2.17
2
1.17
6
0.94
0.959
Very/Good
2.04
2
1.40
25
0.55
Q20
Satisf./Bad
1.50
1.5
1.38
6
1.10
0.834
Very/Good
1.48
1
1.71
25
0.67
Q21
Satisf./Bad
1.00
0.5
1.26
6
1.01
0.060
Very/Good
0.24
0
0.66
25
0.26
Q22
Satisf./Bad
1.33
1.5
1.21
6
0.97
0.916
Very/Good
1.36
1
1.50
25
0.59
Q23
Satisf./Bad
1.50
1.5
1.38
6
1.10
0.959
Very/Good
1.52
2
1.42
25
0.56
Psychological discomfort
Satisf./Bad
7.50
7
4.93
6
3.94
0.598
Very/Good
6.64
7
4.51
25
1.77
Q24
Satisf./Bad
0.17
0
0.41
6
0.33
0.864
Very/Good
0.32
0
0.90
25
0.35
Q25
Satisf./Bad
0.17
0
0.41
6
0.33
0.526
Very/Good
0.08
0
0.28
25
0.11
Q26
Satisf./Bad
0.83
0
1.60
6
1.28
0.493
Very/Good
0.40
0
0.82
25
0.32
Q27
Satisf./Bad
0.17
0
0.41
6
0.33
0.830
Very/Good
0.28
0
0.89
25
0.35
Q28
Satisf./Bad
0.67
0
1.63
6
1.31
0.696
Very/Good
0.76
0
1.36
25
0.53
Q29
Satisf./Bad
1.00
0
1.67
6
1.34
0.906
Very/Good
0.76
0
1.16
25
0.46
Q30
Satisf./Bad
0.50
0
1.22
6
0.98
0.240
Very/Good
0.04
0
0.20
25
0.08
Q31
Satisf./Bad
0.50
0
1.22
6
0.98
0.830
Very/Good
0.44
0
1.23
25
0.48
Q32
Satisf./Bad
1.00
0.5
1.26
6
1.01
0.956
Very/Good
1.04
0
1.34
25
0.52
Physical disability
Satisf./Bad
5.00
1
9.42
6
7.54
0.917
Very/Good
4.12
2
5.42
25
2.12
Q33
Satisf./Bad
0.83
0
1.33
6
1.06
1.000
Very/Good
0.80
0
1.35
25
0.53
Q34
Satisf./Bad
1.33
1
1.37
6
1.09
0.874
Very/Good
1.32
2
1.31
25
0.52
Q35
Satisf./Bad
1.17
0.5
1.47
6
1.18
0.872
Very/Good
1.04
1
1.17
25
0.46
Q36
Satisf./Bad
1.17
0.5
1.60
6
1.28
0.290
Very/Good
0.48
0
0.82
25
0.32
Q37
Satisf./Bad
1.17
0
1.83
6
1.47
1.000
Very/Good
0.96
0
1.27
25
0.50
Q38
Satisf./Bad
0.67
0
1.63
6
1.31
0.640
Very/Good
0.60
0
1.00
25
0.39
Psychological disability
Satisf./Bad
6.33
4
8.14
6
6.51
0.801
Very/Good
5.20
5
4.25
25
1.67
Q39
Satisf./Bad
0.67
0
1.63
6
1.31
1.000
Very/Good
0.44
0
0.96
25
0.38
Q40
Satisf./Bad
0.83
0
1.60
6
1.28
0.930
Very/Good
0.76
0
1.16
25
0.46
Q41
Satisf./Bad
0.83
0
1.60
6
1.28
0.328
Very/Good
0.32
0
0.80
25
0.31
Q42
Satisf./Bad
1.17
0.5
1.60
6
1.28
0.447
Very/Good
0.76
0
1.27
25
0.50
Q43
Satisf./Bad
0.50
0
1.22
6
0.98
0.240
Very/Good
0.04
0
0.20
25
0.08
Social disability
Satisf./Bad
4.00
1
7.46
6
5.97
0.742
Very/Good
2.32
0
3.69
25
1.45
Q44
Satisf./Bad
1.33
1
1.63
6
1.31
0.251
Very/Good
0.52
0
0.77
25
0.30
Q45
Satisf./Bad
1.33
1
1.63
6
1.31
0.014
Very/Good
0.20
0
0.71
25
0.28
Q46
Satisf./Bad
1.50
1.5
1.52
6
1.21
0.002
Very/Good
0.12
0
0.33
25
0.13
Q47
Satisf./Bad
1.17
0.5
1.60
6
1.28
0.189
Very/Good
0.44
0
0.87
25
0.34
Q48
Satisf./Bad
0.50
0
1.22
6
0.98
0.240
Very/Good
0.08
0
0.40
25
0.16
Q49
Satisf./Bad
0.50
0
1.22
6
0.98
0.041
Very/Good
0.00
0
0.00
25
- x -
Handicap
Satisf./Bad
6.33
4
8.33
6
6.67
0.085
Very/Good
1.36
0
2.31
25
0.90
Total OHIP
Satisf./Bad
57.17
50.5
52.94
6
42.36
0.193
Very/Good
26.60
23
20.24
25
7.93
P1
Satisf./Bad
2,67
2,5
1,86
6
1,49
0,174
Very/Good
1,64
1
1,58
25
0,62
P2
Satisf./Bad
2.67
2.5
1.86
6
1.49
0.257
Very/Good
1.84
1
1.65
25
0.65
P3
Satisf./Bad
2.67
3
1.37
6
1.09
0.013
Very/Good
1.04
1
1.24
25
0.49
P4
Satisf./Bad
2.50
1.5
1.97
6
1.58
0.033
Very/Good
0.92
1
0.91
25
0.36
P5
Satisf./Bad
3.17
3.5
2.04
6
1.63
0.009
Very/Good
1.04
1
1.10
25
0.43
P6
Satisf./Bad
2.33
1
2,07
6
1.65
0.009
Very/Good
0.60
1
0.50
25
0.20
P7
Satisf./Bad
2.50
2
1.76
6
1.41
0.015
Very/Good
0.84
1
1.11
25
0.43
P8
Satisf./Bad
2.33
2.5
1.21
6
0.97
0.014
Very/Good
0.96
1
1.27
25
0.50
P9
Satisf./Bad
3.00
3
2.19
6
1.75
0.006
Very/Good
0.72
1
1.06
25
0.42
P10
Satisf./Bad
1.83
1
1.33
6
1.06
0.009
Very/Good
0.64
0
1.04
25
0.41
P11
Satisf./Bad
2.17
2
1.33
6
1.06
0.075
Very/Good
1.16
1
1.21
25
0.48
P12
Satisf./Bad
2.33
2
1.51
6
1.20
0.011
Very/Good
0.80
1
1.00
25
0.39
P13
Satisf./Bad
1.50
1
1.22
6
0.98
0.072
Very/Good
0.68
1
0.69
25
0.27
P14
Satisf./Bad
2.17
1
1.83
6
1.47
0.103
Very/Good
0.96
1
0.98
25
0.38
P15
Satisf./Bad
1.67
1
1.63
6
1.31
0.027
Very/Good
0.60
0
0.76
25
0.30
P16
Satisf./Bad
2.00
1
1.67
6
1.34
0.143
Very/Good
1.16
1
1.34
25
0.53
P17
Satisf./Bad
1.50
1
1.22
6
0.98
0.088
Very/Good
0.88
1
1.20
25
0.47
P18
Satisf./Bad
1.50
1
0.84
6
0.67
0.018
Very/Good
0.64
1
0.76
25
0.30
P19
Satisf./Bad
2.00
1
1.67
6
1.34
0.044
Very/Good
0.84
1
1.03
25
0.40
P20
Satisf./Bad
2.17
1.5
1.60
6
1.28
0.011
Very/Good
0.72
1
0.79
25
0.31
P21
Satisf./Bad
1.83
1
1.33
6
1.06
0.027
Very/Good
0.72
1
0.79
25
0.31
Total
Satisf./Bad
46.50
42.5
24.34
6
19.47
0.009
Very/Good
19.40
23
15.19
25
5.96
Sialo 7: question 7 in the Patient satisfaction post-sialendoscopy questionnaire – (PSPS questionnaire) meaning the overall satisfaction of the patient with sialendoscopy
OHIP oral health impact profile questionnaire—Q1 to Q49
Xerostomia Xerostomia (Xer) questionnaires—P1 to P21
VAS pain Visual Analogic Scale
The comparison of pre- and post-sialendoscopy VAS values (Wilcoxon test) resulted in a score reduction from 7.42 to 1.29 (p < 0.001), showing the efficacy of sialendoscopy in relieving pain after treatment.
Discussion
Synopsis of new findings
This prospective study evaluated the post-sialendoscopy satisfaction by QOL questionnaire results for 37 sialendoscopies in three years. Few studies have focused specifically on the QOL after sialendoscopies; previous specific questionnaires, like the Chronic Obstructive Sialadenitis Symptoms (COSS) Questionnaire [45], have retrospectively addressed the severity of sialadenitis symptoms in sialendoscopy submitted patients, in seven years period with only 66 patients enrolled and, different from our study, they evaluated a past month clinical period.
Our study differs in the complete and prospective way in which the topic was addressed by specific questionnaires of sialendoscopy, xerostomia and OHIP, before and after the procedure, with a good correlation of the result with sialendoscopy, with findings similar to another prospective study with forty patients and specific questionnaire [29] and to date, there are no other comparable studies, despite the growing spread of the technique [31].
Our cohort included most young female patients: 64.5% had sialolithiasis, 35.4% had post-radioiodine; the periodic painful swelling (4.5 times/week), and a long average time until treatment (23.5 months) could have strongly influenced the poor pre-sialendoscopy QOL, once the pre-VAS was 7.42 (p < 0.001). This was anatomically explained by the sensitive gland innervation from trigeminal V3 branches. Our post-sialendoscopy follow-up (14 months) confirmed the successful viability of the sialendoscopy as an organ function-preserving procedure, with a high satisfaction index.
In our cohort, 64.5% of patients suffered from stones obstruction with an average size of 3.77 mm. Nearly 37% were single stones of which 86.5% were successfully treated with sialendoscopy alone, and the remaining with a combined approach. The average time of 139 min (2 h and 31 min), without complications, was comparable with the literature, in the way that some patients (majority with stones and five others with combined-hybrid procedure), have took more time to retrieve the objective, and they took part of the first cases of the study, being interpreted also as a biases; nowadays it took about forty five minutes [5, 46‐48]. The post-VAS pain scale was 1.3 after sialendoscopy (p < 0.001). There was major satisfaction with the procedure, as 3.45 was the overall satisfaction score (p < 0.001), which mainly correlated with stone size (p = 0.049) and was comparable with only one other similar article [29] (Tables 1, 2).
Oral health impact profile and sialendoscopy findings
Overall, 80.6% of patients reported improved symptoms after sialendoscopy in the sialolithiasis clinic (p < 0.001) (Table 3). In the OHIP, the physical pain and psychological discomfort domain scores were mostly impacted by salivary obstruction. As these QOL domains were heavily impacted by obstruction, the sialendoscopy provided relief and truly improved psychological discomfort and physical and psychological deficiencies (p < 0.001) (Table 4), similar to recent studies [32‐34].
Our study limitations were the relatively small number of patients for this amount of time; questionable conclusions due to the interpretation of subjective data on QOL questionnaires, common in this type of studies; the absence of comparative results in literature to ours of specific questionnaires on sialendoscopy; and patient misinterpretation with different types of questions. Nevertheless, our prospective study on post-sialendoscopy satisfaction found high score QOL correlated with stone size.
In our correlation analysis (Table 4), we found a positive correlation with calculi size, that is, larger sialolithiasis and better sialendoscopy satisfaction (p = 0.049). We found the best correlation with question 46 (unable to enjoy people's company) of OHIP, where r = − 0.660. This negative r-correlation shows, inversely, a greater satisfaction with sialendoscopy, as demonstrated in the QOL questionnaire.
In Table 3, the salivary stone symptom correlated with Good satisfaction (p = 0.022) and overall Good satisfaction with sialendoscopy for obstructive disease (p < 0.001), demonstrating the efficacy of sialendoscopy in relieving pain and an enriching QOL.
In Table 4, other significant Very Good correlations of sialendoscopy included the following: OHIP: questions 3, 21, 25, 36, 45, 47, and total deficiency, meaning that OHIP questions prior to sialendoscopy (such as tooth problems, psychological discomfort, depression, and an unsatisfying life) have a strong correlation with Very Good satisfaction after sialendoscopy procedure. This mainly reflects the patient mental status improvement after relief of pain and resolution of the obstructive salivary problems.
Similar results are shown in Table 5, with respect to the satisfaction answer: Very Good/Good and Satisfying/Bad. The main differences occurred on question 17 (p = 0.041), question 45 (p = 0.014), and question 46 (p = 0.002), implying good correlation after the sialendoscopy, in which the procedure ameliorated in some way the prior symptoms.
Xerostomia and sialendoscopy findings
We found good correlation between sialendoscopy satisfaction in Q5 (p = 0.025), Q6 (p = 0.031), Q10 (p = 0.044), Q14 (p = 0.030), Q15 (p = 0.013), and Q18 (p = 0.003) (Table 4). This showed that worries prior to the procedure were positively associated with resolution and satisfaction after sialendoscopy. These findings lead to conclude that when the patient felling of xerostomia were mainly due stenosis problems of various etiologies, the sialendoscopy are the main mean of treatment, similarly to others studies [33, 49].
However, in Table 5, we found a negative correlation between Xer and sialendoscopy satisfaction, where the total score was 46.5 Satisfying/Bad versus Very Good/Good (p = 0.009). These results demonstrated no correlation in sialendoscopy satisfaction, similar to the literature, specifically on cases of mixture of secondary or main duct stenosis, radioiodine treatment for thyroid cancer, and salivary production deficiency, common findings in auto-immune diseases, diabetes mellitus, tobacco smoker and antidepressant medication users [8, 11, 20, 25, 26, 31].
These contradictory results could be explained by the fact that the main disease that determined the stenosis is the same on salivary tissue and acini destruction. As the Poiseuille’s law, these alterations (quality of saliva as viscosity, volume of saliva production determining the pressure gradient across the tubing, duct length and duct diameter) altogether contribute to decreased salivary production and flow; and since the sialendoscopy is a procedure that ameliorate the diameter of the duct, facilitating the saliva flow, it affects only the flow part of equation [50]. Everything else of the salivary production is not achieved and solved by sialendoscopy, and therefore, the final result is the poor satisfaction expressed by patients along time [30, 33]; other explanations are patient misunderstanding, method limitations and the relatively few subjects on the study.
Clinical applications
Our findings support the evident first indication of sialendoscopy for obstructive sialolithiasis treatment and probably a relative time-dependent indication for stenosis/other xerostomia causes due the re-incident nature of the strictures. The positive impact on QOL is clearly evident on the sialolithiasis and barely satisfactory in the stenosis; as result, the surgeon must precisely evaluate the time of each case indication.
The positive satisfaction of sialendoscopy for pain relief in obstructive disease, mainly due to stones while conserving the salivary gland, reaffirms the indication of sialendoscopy as the first alternative for obstructive salivary lithiasis.
Our results can assist clinicians with the appropriate patient selection for sialendoscopy treatment. Additionally, they introduce a new question: When is the best time to indicate sialendoscopy in cases of obstruction due to strictures, where the main cause is inflammation (radioinduced, autoimmune sialodenitis)? Should it only be when they are symptomatic? Or should it be indicated early in the context of the disease? Perhaps more multi-center, prospective studies, with a greater sample size could address this question.
The main goal of the study is to apply these results in our daily clinic, selecting the better temporary moment to perform the procedure and not simply proposing the sialendoscopy act. Our results will help to choose the moment at which sialendoscopy will be indicated as the definitive treatment for obstructions by stones, preserving the gland and getting better QOL, or indicating as "palliative" treatment in cases of inflammatory strictures, expecting a poor improvement on QOL.
Conclusions
Our study on post-sialendoscopy QOL found high score correlated with good patient satisfaction and overall good patient satisfaction after sialendoscopy in sialolithiasis, where 80.6% of symptoms improved.
We found a negative correlation between Xerostomia and post-sialendoscopy satisfaction, meaning poor QOL satisfaction perceived by the patient.
Our findings support the formal indication of sialendoscopy for obstructive sialolithiasis with a positive impact on QOL and probably a relative time-dependent indication for stenosis/other xerostomia causes that little improved QOL satisfaction.
Acknowledgements
We would like to thank to the Statistical team, in the person of Mr. Jimmy Adans Costa Palandi, who performed this precious analysis and to the Editage Group (www.editage.com) for professional English language editing in the review of this manuscript.
Declarations
Ethics approval and consent to participate
This study was approved by the Institutional Ethics Committee (CAAE: 95881418.2.0000.5483, number 2.934.247) in October 2018. The study was conducted in accordance with the Declaration of Helsinki and registered with the WHO Universal Trial Number (UTN) number (U1111-1247-7028) and the Brazilian Clinical Trials Registry (ReBeC), whose number is RBR-6p8zfs. This study is in accordance with the Preferred Reporting of Case Series in Surgery (PROCESS) criteria [36], Strengthening the Reporting of Cohort Studies in Surgery (STROCSS) [37] and the Standards for Quality Improvement Reporting Excellence guidelines (SQUIRE 2.0) [38].
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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Das Karpaltunnelsyndrom ist die häufigste Kompressionsneuropathie peripherer Nerven. Obwohl die Anamnese mit dem nächtlichen Einschlafen der Hand (Brachialgia parästhetica nocturna) sehr typisch ist, ist eine klinisch-neurologische Untersuchung und Elektroneurografie in manchen Fällen auch eine Neurosonografie erforderlich. Im Anfangsstadium sind konservative Maßnahmen (Handgelenksschiene, Ergotherapie) empfehlenswert. Bei nicht Ansprechen der konservativen Therapie oder Auftreten von neurologischen Ausfällen ist eine Dekompression des N. medianus am Karpaltunnel indiziert.
Das Webinar beschäftigt sich mit Fragen und Antworten zu Diagnostik und Klassifikation sowie Möglichkeiten des Ausschlusses von Zusatzverletzungen. Die Referenten erläutern, welche Frakturen konservativ behandelt werden können und wie. Das Webinar beantwortet die Frage nach aktuellen operativen Therapiekonzepten: Welcher Zugang, welches Osteosynthesematerial? Auf was muss bei der Nachbehandlung der distalen Radiusfraktur geachtet werden?
Inhalte des Webinars zur S1-Leitlinie „Empfehlungen zur Therapie der akuten Appendizitis bei Erwachsenen“ sind die Darstellung des Projektes und des Erstellungswegs zur S1-Leitlinie, die Erläuterung der klinischen Relevanz der Klassifikation EAES 2015, die wissenschaftliche Begründung der wichtigsten Empfehlungen und die Darstellung stadiengerechter Therapieoptionen.
