Background
Methods
Study design and data source
I. Preoperative | |
Diet | • Evening before surgery: may eat until midnight • Clear fluids up to 2 h before procedure, including 50 g Carbohydrate in 400 ml (Nutricia ®) |
Bowel preparation | • No systematic use of mechanical bowel preparation; rectal enemas still performed |
Preoperative sedation | • No systematic preoperative sedation, unless anxious crisis |
II. Intraoperative | |
Nausea and vomiting prophylaxis | • Before incision: Dexamethasone 8 mg IV once (4 mg if age > 80 or weight < 50 kg) • Before incision closure: ✓ Droperidol 1.25 mg IV once ✓ Ondansetron 4 mg IV once in high risk patient (Apfel score > 3) |
Fluid balance | • Goal: maintain intraoperative Zero Fluid Balance ✓ crystalloid maintenance administration: 3 ml/kg/h for laparoscopy; 5 ml/kg/h for open ✓ In case of blood loss: replacement according to institutional protocol |
Analgesia | • Continuous AIVOC Remifentanyl at discretion of anesthesiologist, supplemented with IV Ketamine (0.5 mg/kg at induction and 0,15 mg/kg hourly boluses) • IV Lidocaine 1 mg/kg at induction, then 1,5 mg/kg/h until the end of surgery • Before the end of surgery: IV 1000 mg Acetaminophen, 100 mg Ketoprofen (if no contraindication) and 20 mg Nefopam • In case of laparoscopy: injection of Naropein (2 mg/kg maximum) at incision site • In case of laparotomy: bilateral single shot Tap Block with Naropein (2 mg/kg maximum). No epidural analgesia |
III. Postoperative | |
Activity | • Evening of POD 0: out of bed more than 2 h, including sitting in chair • POD 1 and until discharge: out of bed more than 4 h, including deambulation in ward and sitting in chair • Patient up in chair for all meals • Removal of urinary catheter by POD 1 |
Diet | • No nasogastric tube; if nasogastric tube used intraoperatively, removal at extubation • Patient encouraged to start clear fluid 2 h after procedure • POD 0: Patient encouraged to start free diet. In case of difficulties, one to two boxes of liquid nutritional supplement • POD 1 until discharge: free diet. Encourage daily oral fluid intake (1500–2500 mL) |
Analgesia | • Goal: opioid sparing; no IV morphin patient-controlled analgesia • Scheduled oral level II opioids ✓ Izalgi® (Acetominophen 500 mg + Opium powder) orally every 6 h • Scheduled Acetaminophen ✓ Acetaminophen 500 mg orally every 6 h ✓ For patients with no hepatic disease: Maximum Acetaminophen should not exceed 4000 mg/24 h from all sources including Izalgi® • Scheduled NSAIDs if no contraindication: renal impairment with creatinine clearance less than 40 ml/min or hepatic disease ✓ Ketoprofen 100 mg orally twice daily (start no sooner than 6 h after the intraoperative dose), until POD 2 ✓ If patient unable to take NSAIDs: Tramadol 50 mg orally every 6 h. • Breakthrough pain ✓ Oxycodone 5–10 mg orally every 4 h if needed |
Fluid balance | • Peripheral IV catheter locked on departure from PACU • In case of laparotomy: Fluid maintenance at 40 mL/h until 8:00 am the day after surgery and then discontinued |
Preoperative | |
Preadmission education | Patient received preoperative counselling from a nurse and a physician, and a dedicated booklet including information on recovery goals and expectation about hospital stay. |
Selective MBP | No MBP used for resection. |
Carbohydrate loading | Preoperative carbohydrate intake until 2 h before anaesthesia (50 g carbohydrate in 400 mL fluid). |
No long-acting sedation | No long-acting sedating medication used before surgery (e.g., opioids, antihistamines, benzodiazepines). |
Intraoperative | |
Antibiotic prophylaxis | Antibiotic prophylaxis completed prior to surgical incision |
IV Lidocaine | Continuous infusion: 1.5 mg/kg/h from the beginning to the end of surgery. |
Laparoscopic approach | Successfully completed laparoscopic resection. |
Zero Fluid Balanced | Intraoperative maintenance fluids, excluding replacement of blood loss: for laparoscopy: 3 ml/kg/h; for open surgery: 5 ml/kg/h. |
PONV | Multimodal prophylaxis administered, with at least to drugs including Dexamethasone. |
No abdominal or pelvic drainage | No resection-site drainage used. |
Normothermia | Body temperature measured at the end of surgery >36.0 _C. |
Preventive Opioid-sparing Multimodal | Acetaminophen, NSAIDs (unless complication), Nefopam: IV first dose administered intraoperatively. |
Analgesia | Loco-regional analgesia performed (injection at incision site or bilateral TAP block). |
Postoperative | |
Opioid-sparing multimodal analgesia | Use of opioid-sparing strategies including, abdominal trunk block and oral analgesia: acetaminophen, NSAIDs (unless complication), Level II opioids. |
Free diet on POD 0 | Patient received one meal with regular food by POD 0. |
Early mobilization out of bed on POD0 | Patient mobilized out of bed after surgery by POD 0. |
Early ablation of IV fluid infusion | Ablation of intravenous fluid infusion by POD 0. |
Early removal of urinary drainage | Removal of urinary catheter by POD 1. |
TED prophylaxis | TED prophylaxis with low molecular weight heparin. |
Avoidance of nasogastric tube | Nasogastric tube removed at the end of general anaesthesia. |
Statistical analysis
Results
ERP compliance
Characteristics of the study population and surgical procedures
Before ERP(n = 100) | After ERP(n = 100) |
p-value | |
---|---|---|---|
Age (years) | |||
Mean (+/− SD) | 59,01 (+/− 12,35) | 59,37 (+/− 13,13) | NS |
Median (Min/Max) | 60 (16 / 87) | 60 (27 / 91) | |
ASA score: | |||
ASA 1 (%) | 21 | 24 | NS |
ASA 2 (%) | 69 | 65 | |
ASA 3 (%) | 10 | 11 | |
BMI (kg/m2) | |||
Mean (+/− SD) | 24,2 (+/− 4,98) | 27,3 (+/− 7,89) | 0.001 |
Median (Min/Max) | 23 (16 / 41) | 25 (18 / 63) | |
Oncological indications (%)
| |||
Endometrial cancer* | 22 | 42 | 0.003* |
Cervical cancer | 42 | 39 | |
Ovarian cancer | 22 | 14 | |
Other (Border line ovarian tumor, endometrial hyperplasia, CIN) | 14 | 5 | |
Surgical approaches | |||
Conventional lap / Robotic assisted lap | 88 | 87 | NS |
Open | 12 | 13 | |
Conversion to open | 2 | 2 | |
Surgical procedures | NS | ||
Total Hysterectomy** | 43 | 48 | |
Total Hysterectomy** with pelvic lymphadenectomy | 11 | 16 | NS |
Total Hysterectomy** with pelvic and aortic lymphadenectomy | 9 | 9 | |
Isolated Lymphadenectomy: | 37 | 27 | |
Pelvic lymphadenectomy | 12 | 4 | |
Para-aortic lymphadenectomy | 21 | 18 | |
Both | 4 | 5 |
Length of stay
Before ERP(n = 100) | After ERP(n = 100) |
p-value | |
---|---|---|---|
Primary Hospital stay | |||
Mean (+/− SD) | 3.89 (+/− 2.3) | 3.15 (+/− 1.97) | 0.002 |
Median (Min/Max) | 3 (1/ 14) | 2.5 (0 / 11) | |
Hospital stay / Surgical approaches | |||
Minimally Invasive Techniques |
n = 88 |
n = 87 | |
Mean (+/− SD) | 3.33 (+/− 1.58) | 2.67 (+/− 1.29) | 0.003 |
Median (Min/Max) | 3 (1 / 9) | 2 (1 / 9) | |
Conventional laparoscopy |
n = 53 |
n = 53 | |
Mean (+/− SD) | 2.86 (+/− 0.97) | 2.42 (+/− 0.95) | 0.022 |
Median (Min/Max) | 3 (1 / 6) | 2 (1 / 6) | |
Robotically assisted laparoscopy |
n = 35 |
n = 34 | |
Mean (+/− SD) | 4.1 (+/− 2.01) | 3.1 (+/− 1.6) | 0.028 |
Median (Min/Max) | 4 (1 / 9) | 3 (0 / 9) | |
Open surgery |
n = 12 |
n = 13 | |
Mean (+/− SD) | 8 (+/− 2.63) | 6.38 (+/− 2.6) | 0.14 |
Median (Min/Max) | 8 (4 / 14) | 6 (3 / 11) | |
Hospital Stay | |||
≤ 2 days | 24 | 45 | 0.002 |
> 2 days | 76 | 55 |
Postoperative complications and readmissions
Before ERP(n = 100) | After ERP(n = 100) |
p-value | |
---|---|---|---|
Total | 26 | 25 | NS |
Per operative complications | 1 | 2 | NS |
Bladder injury (n = 1) | Bladder injury (n = 1) | ||
Obturator nerve section (n = 1) | |||
Early post operative complications*(during hospitalization) | 11 | 8 | NS |
Grade I/II | 10 | 8 | |
Urinary Infection (n = 3) | Urinary Infection (n = 2) | ||
Ileus (n = 1) | Vaginal Bleeding (n = 2) | ||
Vaginal Bleeding (n = 3) | Lymphorrhea (n = 1) | ||
Lymphorrhea (n = 1) | Obturator nerve injury (n = 1) | ||
Dysuria (n = 2) | Dysuria (n = 2) | ||
Grade III/IV | 1 | 0 | |
Abdominal wall hematoma IIIB (n = 1) | |||
Post operative complications*(after discharge up to 30 days) | 14 | 15 | NS |
Grade I/II | 12 | 12 | |
Lymphocele (n = 6) | Urinary Infection (n = 2)** | ||
Dysuria (n = 2) | Vaginal cuff leakage (n = 1)** | ||
Urinary infection (n = 1)** | Vaginal bleeding (n = 4) | ||
Nephritic colitis (n = 1)** | Lymphocele (n = 4) | ||
Muscular and skeletic pain (n = 2) | Dysesthesia (n = 1) | ||
Grade III/IV | 2 | 3 | |
Chylous ascites IIIA (n = 1)** | Symptomatic lymphocele IIIA (n = 1)** | ||
Symptomatic lymphocele IIIA (n = 1)** | Lymphocele surinfected IIIB (n = 1)** | ||
Deep hematoma IIIB (n = 1)** | |||
Readmissions in relation with post operative complications** | 4 | 6 | NS |