A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- correction of pelvic organ prolapse
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Exclusion Criteria
- •Age > 75 years
- •Severe cardiovascular or respiratory disease
- •Pregnancy
Arms & Interventions
posterior mesh no attachment
laparoscopic sacral colpopexy with no fixation of posterior mesh
Intervention: laparoscopic sacral colpopexy with posterior mesh no attachment (Procedure)
posterior mesh attachment
laparoscopic sacral colpopexy with fixation of posterior mesh by suture
Intervention: laparoscopic sacral colpopexy with posterior mesh attachment (Procedure)
Outcomes
Primary Outcomes
correction of pelvic organ prolapse
Time Frame: 1 year
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
Secondary Outcomes
- rate of recurrence(1 year)
- long term outcomes(1 year)
Investigators
Maurizio Guido
principal investigator, Director of gynaecologic and obstetric department
Catholic University of the Sacred Heart