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OpenTrials
Completed

NCT Number: NCT03445442

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.

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Key information

Age range

70 year–80 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SCP

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Post-operative complications

    Time frame: 12 months follow-up

    All complications are recorded, corresponding to Clavien Dindo classification.

Secondary outcomes

  1. Anatomical success rate

    Time frame: 12 months follow-up

    Assessed by recovery time and anatomical correction

  2. Surgical satisfaction

    Time frame: 12 months follow-up

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2017
First posted
Feb 26, 2018
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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