Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Unrecognized Condition Clinical Trial

Official title:

Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445442
• Other study ID #: URO-BASE02
• Status: Completed
• First received: February 12, 2018
• Last updated: March 20, 2018
• Start date: January 1, 2011
• Est. completion date: April 5, 2017

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 5, 2017
• Est. primary completion date: December 1, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prolapse
• Unrecognized Condition

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

References & Publications (28)

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. — View Citation

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. French. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. French. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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:CD012376. Review. — View Citation

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. — View Citation

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. 2009:743831. doi: 10.1155/2009/743831. Epub 2009 Aug 24. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Samuelsson EC, Victor FT, Tibblin G, Svärdsudd 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2003 Mar 28. Erratum in: Int Urogynecol J Pelvic Floor Dysfunct. 2003 Dec;14(6):437-8. — View Citation

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complications	All complications are recorded, corresponding to Clavien Dindo classification.	12 months follow-up
Secondary	Anatomical success rate	Assessed by recovery time and anatomical correction	12 months follow-up
Secondary	Surgical satisfaction	Assessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)	12 months follow-up