Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. 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):1623–1629

    Article  PubMed  Google Scholar 

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

    Article  CAS  Google Scholar 

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

    PubMed  CAS  Google Scholar 

  4. 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):323–327

    PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

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

    Article  PubMed  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  9. 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

    Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    PubMed  CAS  Google Scholar 

  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):1459–1467

    Article  PubMed  Google Scholar 

  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):1089–1103

    Article  PubMed  Google Scholar 

  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):273–279

    Article  PubMed  Google Scholar 

  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):77–82

    Article  Google Scholar 

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

    Article  PubMed  Google Scholar 

  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):415–21

    Article  Google Scholar 

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

    Article  Google Scholar 

  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):10–17

    Article  PubMed  CAS  Google Scholar 

  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):523–528

    Article  Google Scholar 

  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

    Google Scholar 

  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

    Google Scholar 

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

    Article  Google Scholar 

  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):989–994

    Article  PubMed  CAS  Google Scholar 

  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):1152–1160

    Article  PubMed  CAS  Google Scholar 

  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):4–20

    Article  Google Scholar 

  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):2–12

    Article  Google Scholar 

  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):1005–1013

    Article  PubMed  Google Scholar 

  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

    Google Scholar 

  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):308–314

    Article  PubMed  Google Scholar 

  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):1557–1566

    Article  PubMed  CAS  Google Scholar 

  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

    Google Scholar 

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

    Article  Google Scholar 

Download references

Acknowledgements

Prof. R. Freeman is partially supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula. The views expressed in this piece are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.

Sister Heidi Hollands, research midwife to the Urogynaecology Unit, Plymouth Hospitals NHS Trust, for her help with data collection and preparation.

Mr Tony Smith, Consultant Urogynaecologist, Manchester for his help with the surgical training session and standardisation of techniques (see methods).

Ethics

LREC 6/Q2103/13 Plymouth Hospitals NHS Trust 2006.

Conflicts of interest

R. Freeman: speaker fees for educational meetings sponsored by Astellas and Pfizer; K. Pantazis: none; A. Thomson: Ethicon Women’s Health, GYNECARE; J. Frappell: none; L. Bombieri: none; P. Moran: Astellas, Boston Scientific, American Medical Systems; M. Slack: consultancy agreements with GYNECARE, Women’s Health and Urology, Astellas and Pfizer pharmaceuticals; P. Scott: none; M. Waterfield: none.

Funding

Competitive grant from the Plymouth Surgical Services Trust.

Contributorship

RM Freeman: designed the study, supervised and assisted in protocol development, patient recruitment, was a surgeon for the open procedures, data analysis and writing of the manuscript; K Pantazis, research fellow: protocol writing, patient recruitment, data collection and analysis; A Thomson: patient recruitment, surgeon for laparoscopic procedures, data collection, review of data and manuscript; J Frappell: patient recruitment, surgeon for laparoscopic procedures, review of data and manuscript; L Bombieri: Review of protocol development, patient recruitment, surgeon for open procedures, review of data and manuscript; P Moran: patient recruitment, surgeon for open procedures, data collection, review of data and manuscript; P Scott: patient recruitment, surgeon for laparoscopic procedures, review of data and manuscript; M Slack: patient recruitment, surgeon for open and laparoscopic procedures, review of data and manuscript; M Waterfield, statistician and research co-ordinator: study and protocol development, data preparation, statistical analysis and review of manuscript.

Author information

Authors and Affiliations

  1. Urogynaecology Unit, Directorate of Women’s Health, Derriford Hospital, Plymouth, PL6 8DH, UK

    R. M. Freeman, K. Pantazis, L. Bombieri & M. Waterfield

  2. Minimal Access Surgery Group, Plymouth Hospitals NHS Trust, Plymouth, UK

    J. Frappell & P. Scott

  3. Worcestershire Acute Hospitals NHS Trust, Worcester, UK

    A. Thomson & P. Moran

  4. Addenbrooke’s Hospital Univ. of Cambridge Teaching Hospital Trust, Cambridge, UK

    M. Slack

  5. Peninsula College of Medicine and Dentistry, Plymouth, UK

    R. M. Freeman & M. Waterfield

Authors
  1. R. M. Freeman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. K. Pantazis
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. A. Thomson
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. J. Frappell
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. L. Bombieri
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. P. Moran
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. M. Slack
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. P. Scott
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. M. Waterfield
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to R. M. Freeman.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Freeman, R.M., Pantazis, K., Thomson, A. et al. A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study. Int Urogynecol J 24, 377–384 (2013). https://doi.org/10.1007/s00192-012-1885-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00192-012-1885-x

Keywords

Search

Navigation