NCT04378400|Enrolling By Invitation
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Sponsor study identifier
observational
250
1 country
1
Study Start
September 29, 2020
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2020
Actual (reported)May 7, 2020
Actual (reported)September 29, 2020
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
UZ Leuven
Leuven, 3000, Belgium
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.
First Submitted
May 4, 2020
First Posted
May 7, 2020
Study Start
September 29, 2020
Actual (reported)Primary Completion
December 2025
Estimated (date passed)Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 15, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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