A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
1 other identifier
interventional
150
1 country
1
Brief Summary
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2020
CompletedStudy Start
First participant enrolled
April 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJuly 24, 2020
July 1, 2020
1.4 years
April 21, 2020
July 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
correction of pelvic organ prolapse
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
1 year
Secondary Outcomes (2)
rate of recurrence
1 year
long term outcomes
1 year
Study Arms (2)
posterior mesh no attachment
ACTIVE COMPARATORlaparoscopic sacral colpopexy with no fixation of posterior mesh
posterior mesh attachment
ACTIVE COMPARATORlaparoscopic sacral colpopexy with fixation of posterior mesh by suture
Interventions
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina
Eligibility Criteria
You may qualify if:
- patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
You may not qualify if:
- Age \> 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catholic University of the Sacred Heartlead
- Miulli General Hospitalcollaborator
Study Sites (1)
ospedale regionale Miulli
Acquaviva delle Fonti, Bari, 70021, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator, Director of gynaecologic and obstetric department
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
April 23, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
July 24, 2020
Record last verified: 2020-07