Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Centre Hospitalier Universitaire de Nice214 enrolled

Overview

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.

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

214

Conditions

Unrecognized Condition

Interventions

SCPPROCEDURE

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

NTRPROCEDURE

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.

VMRPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 70 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Post-operative complications

All complications are recorded, corresponding to Clavien Dindo classification.

Time frame: 12 months follow-up

Secondary Outcomes

Anatomical success rate

Assessed by recovery time and anatomical correction

Time frame: 12 months follow-up

Surgical satisfaction

Assessed by the validated Surgical Satisfaction Questionnaire (SSQ-8)

Time frame: 12 months follow-up

Data from ClinicalTrials.gov

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