Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

The investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80 years old, to see which procedure in terms of treatment-related complications of SCP, VMR and NTR by comparing the operative and functional outcomes in this patient population.

Study Overview

• Status: Completed
• Conditions: Unrecognized Condition
• Intervention / Treatment: Procedure: SCP; Procedure: NTR; Procedure: VMR

Detailed Description

Pelvic organ prolapse (POP) is a global health care issue that could have a significant impact on pelvic floor function and quality of life (QOL), while seldom having the potential to be life-threatening. Prevalence of POP increases with age. In women older than 80, 11% undergo a surgical procedure. The incidence of degenerative diseases and multiple co-morbidities increases with age, and advanced age is also associated with an increase in morbidity generally for gynecologic procedures. Furthermore, greater comorbidity beforehand can predispose patients to postoperative complications such as bleeding, hematoma, pain, infectious. As a result hospital stays are longer and the surgical results are compromised.

Surgical techniques should optimize functional results and minimize complications. In POP surgery, younger women are good candidates for sacrocolpopexy (SCP), because of the improved long term functional result, while women older than 80 may have a satisfactory outcome with fewer complication with a vaginal repair with mesh (VMR) or native tissue (NTR). The increasing prevalence of POP, and the increasing population of women aged 70-80 requires an evaluation of the appropriate surgical management since women in this age group may be candidates for all types of surgical repair.

• Study Type: Observational
• Enrollment (Actual): 214

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years to 76 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study cohort is selected from our institution. The study involves elderly females over 70 years old with advanced pelvic organ prolapse.

Description

Inclusion Criteria:

• Patients with a pelvic organ prolapse
• Patients aged between 70 and 80 years old
• Patients with symptomatic anterior, apical and/or posterior compartment prolapse, stage 2 or greater

Exclusion Criteria:

• Patients with a previous history of pelvic surgery for a cancer diagnosis are excluded
• Patients with a surgical repair specific to the existing defect site (For group 2)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Sacrocolpopexy (SCP)	Procedure: SCP; Sacrocolpopexy (SCP) aims to secure the anterior vaginal wall, the uterus more or less the posterior vaginal wall using polypropylene prostheses and to secure them to the presacral ligament to restore the patient's anatomical features and improve pelvic symptoms
Group 2; Native tissue repair surgery (NTR)	Procedure: NTR; Native tissue repair surgery (NTR) consist of site-specific surgical repair of the existing defect (anterior and/or posterior) using non-absorbable sutures. Specifically, anterior and/or posterior colporrhaphy for cystocele and rectocele respectively after adequate hydrodissection of the vesicovaginal or rectovaginal space.
Group 3; Vaginal mesh repair surgery (VMR)	Procedure: VMR; Vaginal mesh repair surgery (VMR) is performed using a single-incision mesh system. A single vertical incision is made in the anterior and/or posterior vaginal wall. A full-thickness dissection is performed laterally and apically to the ischial spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	All complications are recorded, corresponding to Clavien Dindo classification.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical success rate	Assessed by recovery time and anatomical correction	12 months follow-up
Surgical satisfaction	Assessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)	12 months follow-up

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Publications and helpful links

General Publications

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
• Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
• Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.
• Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4.
• Samuelsson EC, Victor FT, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 1):299-305. doi: 10.1016/s0002-9378(99)70203-6.
• Gomelsky A, Penson DF, Dmochowski RR. Pelvic organ prolapse (POP) surgery: the evidence for the repairs. BJU Int. 2011 Jun;107(11):1704-19. doi: 10.1111/j.1464-410X.2011.10123.x.
• Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gynecol. 2001 Jun;184(7):1496-501; discussion 1501-3. doi: 10.1067/mob.2001.114868.
• Stepp KJ, Barber MD, Yoo EH, Whiteside JL, Paraiso MF, Walters MD. Incidence of perioperative complications of urogynecologic surgery in elderly women. Am J Obstet Gynecol. 2005 May;192(5):1630-6. doi: 10.1016/j.ajog.2004.11.026.
• Tabata T, Yamawaki T, Ida M, Nishimura K, Nose Y, Yabana T. Clinical value of dilatation and curettage for abnormal uterine bleeding. Arch Gynecol Obstet. 2001 Jan;264(4):174-6. doi: 10.1007/s004040000100.
• Hornemann A, Kamischke A, Luedders DW, Beyer DA, Diedrich K, Bohlmann MK. Advanced age is a risk factor for higher grade perineal lacerations during delivery in nulliparous women. Arch Gynecol Obstet. 2010 Jan;281(1):59-64. doi: 10.1007/s00404-009-1063-7. Epub 2009 Mar 31.
• Sabbagh R, Mandron E, Piussan J, Brychaert PE, Tu le M. Long-term anatomical and functional results of laparoscopic promontofixation for pelvic organ prolapse. BJU Int. 2010 Sep;106(6):861-6. doi: 10.1111/j.1464-410X.2009.09173.x. Epub 2010 Jan 19.
• Gerten KA, Markland AD, Lloyd LK, Richter HE. Prolapse and incontinence surgery in older women. J Urol. 2008 Jun;179(6):2111-8. doi: 10.1016/j.juro.2008.01.089.
• Visco AG, Wei JT, McClure LA, Handa VL, Nygaard IE; Pelvic Floor Disorders Network. Effects of examination technique modifications on pelvic organ prolapse quantification (POP-Q) results. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):136-40. doi: 10.1007/s00192-002-1030-3. Epub 2003 Mar 28. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2003 Dec;14(6):437-8.
• Giuly J, Cravello L, D'Ercole C, Roger V, Porcu G, Blanc B. [Richter's spinofixation in vaginal prolapse]. Chirurgie. 1997;122(7):430-4. French.
• Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. doi: 10.1016/j.ajog.2007.12.036.
• King SW, Jefferis H, Jackson S, Marfin AG, Price N. Laparoscopic uterovaginal prolapse surgery in the elderly: feasibility and outcomes. Gynecol Surg. 2017;14(1):2. doi: 10.1186/s10397-017-1000-x. Epub 2017 Apr 11.
• Sung VW, Weitzen S, Sokol ER, Rardin CR, Myers DL. Effect of patient age on increasing morbidity and mortality following urogynecologic surgery. Am J Obstet Gynecol. 2006 May;194(5):1411-7. doi: 10.1016/j.ajog.2006.01.050.
• Leung JM, Dzankic S. Relative importance of preoperative health status versus intraoperative factors in predicting postoperative adverse outcomes in geriatric surgical patients. J Am Geriatr Soc. 2001 Aug;49(8):1080-5. doi: 10.1046/j.1532-5415.2001.49212.x.
• Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.
• Greer JA, Northington GM, Harvie HS, Segal S, Johnson JC, Arya LA. Functional status and postoperative morbidity in older women with prolapse. J Urol. 2013 Sep;190(3):948-52. doi: 10.1016/j.juro.2013.03.004. Epub 2013 Mar 6.
• Keys T, Campeau L, Badlani G. Synthetic mesh in the surgical repair of pelvic organ prolapse: current status and future directions. Urology. 2012 Aug;80(2):237-43. doi: 10.1016/j.urology.2012.04.008. Epub 2012 May 23.
• Belot F, Collinet P, Debodinance P, Ha Duc E, Lucot JP, Cosson M. [Risk factors for prosthesis exposure in treatment of genital prolapse via the vaginal approach]. Gynecol Obstet Fertil. 2005 Dec;33(12):970-4. doi: 10.1016/j.gyobfe.2005.10.023. French.
• Agarwala N, Hasiak N, Shade M. Laparoscopic sacral colpopexy with Gynemesh as graft material--experience and results. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):577-83. doi: 10.1016/j.jmig.2007.03.005.
• Su TH, Lau HH, Huang WC, Hsieh CH, Chang RC, Su CH. Single-incision mesh repair versus traditional native tissue repair for pelvic organ prolapse: results of a cohort study. Int Urogynecol J. 2014 Jul;25(7):901-8. doi: 10.1007/s00192-013-2294-5. Epub 2014 Jan 28.
• Nieminen K, Hiltunen R, Takala T, Heiskanen E, Merikari M, Niemi K, Heinonen PK. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol. 2010 Sep;203(3):235.e1-8. doi: 10.1016/j.ajog.2010.03.030. Epub 2010 May 21.
• Moore RD, Miklos JR. Vaginal repair of cystocele with anterior wall mesh via transobturator route: efficacy and complications with up to 3-year followup. Adv Urol. 2009;2009:743831. doi: 10.1155/2009/743831. Epub 2009 Aug 24.
• Lee U, Wolff EM, Kobashi KC. Native tissue repairs in anterior vaginal prolapse surgery: examining definitions of surgical success in the mesh era. Curr Opin Urol. 2012 Jul;22(4):265-70. doi: 10.1097/MOU.0b013e32835459bb.
• Tibi B, Vincens E, Durand M, Bentellis I, Salet-Lizee D, Kane A, Gadonneix P, Severac F, Ahallal Y, Chevallier D, Villet R. Comparison of different surgical techniques for pelvic floor repair in elderly women: a multi-institutional study. Arch Gynecol Obstet. 2019 Apr;299(4):1007-1013. doi: 10.1007/s00404-019-05076-1. Epub 2019 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 5, 2017

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Pelvic Organ Prolapse; Sacrocolpopexy; Native tissue repair; Vaginal mesh repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: URO-BASE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: CFU, Publication at the European Journal in February 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No