An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.

NCT04378400 | Enrolling By Invitation

• 1 other identifier: S63523
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.

Conditions

Vault Prolapse, Vaginal

Keywords

sacropexy; audit

Outcome Measures

Primary Outcomes (1)

• Subjective Success Rate

  Subjective Success assessed by the Patient Global Impression of Change (PGI-C) tool, which is a 5-point Likert scale, where the patients are asked the following question at the follow up visit: "Compared with how you were doing before your recent pelvic floor operation, would you say that now you are: "much better", "a little better", "about the same", "a little worse" or "much worse".

  Up to 10 years postoperative

Secondary Outcomes (5)

• Objective success

  Up to 10 years postoperative

• Postoperative complications

  Up to 10 years postoperative

• Reintervention rate

  Up to 10 years postoperative

• Postoperative graft related complications (GRC)

  Up to 10 years postoperative

• Prolapse Quality of Life (P-QoL)

  Up to 10 years postoperative

Interventions

Sacrocolpopexy PROCEDURE

Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Since our last audit (April 30, 2014), we have operated on more than probably another 250 patients, who will be contacted. Based on our previous experience, we expect a 85% response rate.

You may qualify if:

• Having undergone laparoscopic sacrocolpoexy at our unit.
• Agreeing to participate in the study, including completion of study-related procedures, evaluations and questionnaires, and giving informed consent.
• Follow up period of at least 6 months since the operation.

You may not qualify if:

• None apart from not meeting the above criteria

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Page AS, Cattani L, Pacquee S, Claerhout F, Callewaert G, Housmans S, Van der Aa F, D'Hoore A, Deprest J. Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh. Obstet Gynecol. 2023 Jan 1;141(1):189-198. doi: 10.1097/AOG.0000000000005021. Epub 2022 Nov 30.

  PMID: 36701619 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: September 29, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)