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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 4, 2020

Keywords

ClinConnect Summary

This is an ongoing observational audit at KU Leuven in Leuven, Belgium, studying long-term results after laparoscopic sacrocolpopexy, a surgery used to fix vaginal vault prolapse or descent of the cervix. The team plans to follow about 250 women for up to 10 years to see how they do from the patient’s point of view (subjective success) and with medical checks. They will also track whether the prolapse is controlled on exam around 12 months after surgery (objective success), any surgical complications, any need for additional procedures, problems related to the graft/mesh, and how the prolapse affects quality of life.

Eligible participants are women who have already had the laparoscopic sacrocolpopexy at this unit, are willing to join, and are at least 6 months post-operation. The study is enrolling by invitation and does not involve a drug or new device trial; there is no sharing of individual patient data. Participation involves completing questionnaires and having follow-up exams by an independent clinician. The goal is to learn from many cases to improve counseling and care, and to compare results with earlier data and other centers.

Gender

FEMALE

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