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Enrolling by invitation NCT04378400

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

Observational Vault Prolapse, Vaginal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacrocolpopexy.
Who it may be relevant to
Registry conditions: Vault Prolapse, Vaginal. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.

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.

The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.

High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.

Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.

Interventions

  • Procedure Sacrocolpopexy
    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.

Primary outcome measures

  • Subjective Success Rate [Time frame: Up to 10 years postoperative]
Secondary outcome measures (5)
  • Objective success [Time frame: Up to 10 years postoperative]
  • Postoperative complications [Time frame: Up to 10 years postoperative]
  • Reintervention rate [Time frame: Up to 10 years postoperative]
  • Postoperative graft related complications (GRC) [Time frame: Up to 10 years postoperative]
  • Prolapse Quality of Life (P-QoL) [Time frame: Up to 10 years postoperative]

Eligibility criteria

Inclusion criteria

To be eligible, female subjects must meet the following inclusion criteria:

  • 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.

Exclusion criteria

None apart from not meeting the above criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Publications

  • 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

Identifiers

NCT: NCT04378400 · S63523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗