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Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03445442
Enrollment
214
Registered
2018-02-26
Start date
2011-01-01
Completion date
2017-04-05
Last updated
2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unrecognized Condition

Keywords

Elderly, Native tissue repair, Pelvic Organ Prolapse, Sacrocolpopexy, Vaginal mesh repair

Brief 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.

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.

Interventions

PROCEDURESCP

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

PROCEDURENTR

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.

PROCEDUREVMR

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
70 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Post-operative complications12 months follow-upAll complications are recorded, corresponding to Clavien Dindo classification.

Secondary

MeasureTime frameDescription
Surgical satisfaction12 months follow-upAssessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)
Anatomical success rate12 months follow-upAssessed by recovery time and anatomical correction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026