nach oben

Erschienen in:

01.03.2013 | Original Article

A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study

verfasst von: R. M. Freeman, K. Pantazis, A. Thomson, J. Frappell, L. Bombieri, P. Moran, M. Slack, P. Scott, M. Waterfield

Erschienen in: International Urogynecology Journal | Ausgabe 3/2013

Einloggen, um Zugang zu erhalten

Abstract

Introduction and hypothesis

This prospective multi-centre true two-sided equivalence trial was designed to test the clinical equivalence of open (ASCP) and laparoscopic (LSCP) sacrocolpopexy using objective and subjective outcomes

Methods

The study was carried out in three urogynaecology units in England, UK and the patient population consisted of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions were either abdominal or laparoscopic sacrocolpopexy following randomisation to one of the types of surgery.

Results

For the primary outcome (point C on the POP-Q) the results at 1 year were −6.63 cm for the open ASCP and −6.67 cm for the LSCP respectively. Subjective outcomes at 1 year showed that 90% of the ASCP group and 80% of the LSCP group were “much better”. There were improvements with regard to blood loss, haemoglobin and shorter length of stay in the LSCP group compared with the ASCP group.

Conclusion

This fully powered randomised controlled trial comparing open and laparoscopic sacrocolpopexy has shown clinical equivalence.

Dällenbach P, Kaelin-Gambirasio I, Jacob S, Dubuisson JB, Boulvain M (2008) Incidence rate and risk factors for vaginal vault prolapse repair after hysterectomy. Int Urogynecol J Pelvic Floor Dysfunct 19(12):1623–1629PubMedCrossRef

Mant J, Painter R, Vessey M (1997) Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. BJOG 104(5):579–585CrossRef

Snyder TE, Krantz KE (1991) Abdominal-retroperitoneal sacral colpopexy for the correction of vaginal prolapse. Obstet Gynecol 77(6):944–949PubMed

Timmons MC, Addison WA, Addison SB, Cavenar MG (1992) Abdominal sacral colpopexy in 163 women with posthysterectomy vaginal vault prolapse and enterocele. Evolution of operative techniques. J Reprod Med 37(4):323–327PubMed

Hilger WS, Poulson M, Norton PA (2003) Long-term results of abdominal sacrocolpopexy. Am J Obstet Gynecol 189(6):1606–1610PubMedCrossRef

Maher C et al (2007) Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev (3):CD004014

Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H (2004) Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 104(4):805–823PubMedCrossRef

Lane FE (1962) Repair of post-hysterectomy vaginal vault prolapse. Obstet Gynecol 20:72–77PubMedCrossRef

Timmons MC (2001) Abdominal sacral colpopexy. In: Cardozo L, Staskin D (eds) Textbook of female urology and urogynaecology. Isis Medical Media, London, pp 667–674

10.

Marinkovic SP, Stanton SL (2003) Triple compartment prolapse: sacrocolpopexy with anterior and posterior mesh extensions. BJOG 110(3):323–326PubMedCrossRef

11.

Nezhat CH, Nezhat F, Nezhat C (1994) Laparoscopic sacral colpopexy for vaginal vault prolapse. Obstet Gynecol 84(5):885–888PubMed

12.

Claerhout F, De Ridder D, Roovers JP, Rommens H, Spelzini F, Vandenbroucke V (2009) Medium-term anatomic and functional results of laparoscopic sacrocolpopexy beyond the learning curve. Eur Urol 55(6):1459–1467PubMedCrossRef

13.

Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G (2009) The current status of laparoscopic sacrocolpopexy: a review. Eur Urol 55(5):1089–1103PubMedCrossRef

14.

Klauschie JL, Suozzi BA, O’Brien MM, McBride AW (2009) A comparison of laparoscopic and abdominal sacral colpopexy: objective outcome and perioperative differences. Int Urogynecol J Pelvic Floor Dysfunct 20(3):273–279PubMedCrossRef

15.

Price N, Slack A, Jackson SR (2011) Laparoscopic sacrocolpopexy: an observational study of functional and anatomical outcomes. Int Urogynecol J Pelvic Floor Dysfunct 22(1):77–82CrossRef

16.

Ross JW, Preston M (2005) Laparoscopic sacrocolpopexy for severe vaginal vault prolapse: five-year outcome. J Minim Invasive Gynecol 12(3):221–226PubMedCrossRef

17.

Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, Swift S, Whitmore K, Ghoniem G, de Ridder D (2012) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 23(5):527–535, Neurourol Urodyn (4):415–21CrossRef

18.

Mahendran D (1996) Laparoscopic sacrocolpopexy in the management of vaginal vault prolapse. Gynaecol Endosc 5:217–222CrossRef

19.

Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175(1):10–17PubMedCrossRef

20.

Srikrishna S, Robinson D, Cardozo L (2010) Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 21(5):523–528CrossRef

21.

Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S (2005) P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 16(3):176–81

22.

Hiller L, Radley S, Mann CH, Radley SC, Begum G, Pretlove SJ, Salaman JH (2002) Development and validation of a questionnaire for the assessment of bowel and lower urinary tract symptoms in women. BJOG;109(4):413–23

23.

Devereaux PJ, Bhandari M, Clarke M, Montori VM et al (2005) Need for expertise based randomised controlled trials. BMJ 33(7482):88CrossRef

24.

Majeed AW, Troy G, Nicholl JP, Smythe A, Reed MW, Stoddard CJ, Peacock J, Johnson AG (1996) Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet 347(9007):989–994PubMedCrossRef

25.

Piaggio G, Troy G, Nicholl JP, Smythe A et al (2006) Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 295(10):1152–1160PubMedCrossRef

26.

Haylen BT, de Ridder D, Freeman RM, Swift SE et al (2010) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J Pelvic Floor Dysfunct 21(1):5–26, Neurourol Urodyn 29(1):4–20CrossRef

27.

Haylen BT, Freeman RM, Swift SE, Cosson M et al (2011) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J Pelvic Floor Dysfunct 22(1):3–15, Neurourol Urodyn 30(1):2–12CrossRef

28.

NICE (2009) http://guidance.nice.org.uk/IPG283/Guidance/pdf/English

29.

Paraiso MF, Jelovsek JE, Frick A, Chen CC, Barber MD (2011) Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol 118(5):1005–1013PubMedCrossRef

30.

Collins SA, Tulikangas PK, O’Sullivan DM (2012) Effect of surgical approach on physical activity and pain control after sacral colpopexy. Am J Obstet Gynecol 206(5):438.e1–6

31.

Huebner M, Krzonkalla M, Tunn R (2009) Abdominal sacrocolpopexy–standardized surgical technique, perioperative management and outcome in women with posthysterectomy vaginal vault prolapse. Gynakol Geburtshilfliche Rundsch 49(4):308–314PubMedCrossRef

32.

Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE et al (2006) Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 354(15):1557–1566PubMedCrossRef

33.

Patel M, O’Sullivan D, Tulikangas PK (2009) A comparison of costs for abdominal, laparoscopic and robotic-assisted sacral colpopexy. Int Urogynecol J Pelvic Floor Dysfunct 20:223–228

34.

McDermott CD, Hale DS (2009) Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin N Am 36(3):585–614CrossRef

Titel: A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study
verfasst von: R. M. Freeman
K. Pantazis
A. Thomson
J. Frappell
L. Bombieri
P. Moran
M. Slack
P. Scott
M. Waterfield
Publikationsdatum: 01.03.2013
Verlag: Springer-Verlag
Erschienen in: International Urogynecology Journal / Ausgabe 3/2013
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-012-1885-x

Neu im Fachgebiet Gynäkologie und Geburtshilfe

23.04.2024 | Medikamente in Schwangerschaft und Stillzeit | Nachrichten

Update Gynäkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert – ganz bequem per eMail.

Newsletter bestellen

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

Neu im Fachgebiet Gynäkologie und Geburtshilfe

ICI-Therapie in der Schwangerschaft wird gut toleriert

Weniger postpartale Depressionen nach Esketamin-Einmalgabe

Bei RSV-Impfung vor 60. Lebensjahr über Off-Label-Gebrauch aufklären!

Harnwegsinfektprophylaxe: Es geht auch ohne Antibiotika

Update Gynäkologie

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 3/2013

Obstetric fistula: the use of urethral plugs for the management of persistent urinary incontinence following successful repair

Midurethral slings for women with urodynamic mixed incontinence: what to expect?

Incidence and risk factors of postoperative stress urinary incontinence following laparoscopic sacrocolpopexy in patients with negative preoperative prolapse reduction stress testing

Peri-operative physiotherapy to prevent recurrent symptoms and treatment following prolapse surgery: supported by evidence or not?

Laparoscopic sacrocolpopexy versus transvaginal mesh for recurrent pelvic organ prolapse

Delayed vaginal and urethral mesh exposure: 10 years after TVT surgery

Neu im Fachgebiet Gynäkologie und Geburtshilfe

ICI-Therapie in der Schwangerschaft wird gut toleriert

Weniger postpartale Depressionen nach Esketamin-Einmalgabe

Bei RSV-Impfung vor 60. Lebensjahr über Off-Label-Gebrauch aufklären!

Harnwegsinfektprophylaxe: Es geht auch ohne Antibiotika

Update Gynäkologie