Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Completed

• Conditions: Unrecognized Condition
• Interventions: Procedure: NTR; Procedure: VMR; Procedure: SCP

• Registration Number: NCT03445442
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2012-12-01
• Study Completion: 2017-04-05
• Status Verified: 2018-02
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	NTR	Native tissue repair surgery (NTR)
Group 3	VMR	Vaginal mesh repair surgery (VMR)
Group 1	SCP	Sacrocolpopexy (SCP)

Primary Outcome Measures

Name	Time	Method
Post-operative complications	12 months follow-up	All complications are recorded, corresponding to Clavien Dindo classification.

Secondary Outcome Measures

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