Clinical trial NCT04378400: An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
Official title: An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Vault Prolapse, Vaginal
Keywords: sacropexy
audit
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

None apart from not meeting the above criteria

Primary outcomes:
measure: Subjective Success Rate
timeFrame: Up to 10 years postoperative
Secondary outcomes:
measure: Objective success
timeFrame: Up to 10 years postoperative
measure: Postoperative complications
timeFrame: Up to 10 years postoperative
measure: Reintervention rate
timeFrame: Up to 10 years postoperative
measure: Postoperative graft related complications (GRC)
timeFrame: Up to 10 years postoperative
measure: Prolapse Quality of Life (P-QoL)
timeFrame: Up to 10 years postoperative
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: