NCT03582410

Brief Summary

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

June 6, 2018

Last Update Submit

March 28, 2020

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Number of patients with anatomical correction of the prolapse

    Anatomical correction of the prolapse evaluated by gynecological visit

    1 year

Secondary Outcomes (3)

  • rate mesh erosion

    1 year

  • long term outcomes

    1 year

  • Rate of recurrence

    1 year

Study Arms (2)

Absorbable suture

ACTIVE COMPARATOR

laparoscopic sacral colpopexy with absorbable suture

Procedure: laparoscopic sacral colpopexy with absorbable suture

Non absorbable suture

ACTIVE COMPARATOR

laparoscopic sacral colpopexy with non absorbable suture

Procedure: laparoscopic sacral colpopexy with non absorbable suture

Interventions

laparoscopic sacral colpopexy with absorbable suturePROCEDURE

laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture

Absorbable suture
laparoscopic sacral colpopexy with non absorbable suturePROCEDURE

laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture

Non absorbable suture

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

ospedale regionale Miulli

Acquaviva delle Fonti, Bari, 70021, Italy

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

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
Clinical Professor

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 11, 2018

Study Start

July 10, 2018

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

IT(1)