Laparoscopic Sacrocolpopexy Versus POPS in the Management... | NCT02911584

Studies
Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

NCT02911584

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Dec 6, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopic procedure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

May 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Sep 15, 2016

First Submission Date that Met QC Criteria

Sep 21, 2016

First Posted Date

Sep 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2017

Last Update Posted Date

Dec 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valeria Tagliaferri, Medical Doctor, Miulli General HospitalPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Name	Class
Miulli General Hospital	OTHER

Description Module

Brief Summary

This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacral colpopexy	Active Comparator	Laparoscopic procedure	Procedure: Laparoscopic procedure
POPS	Active Comparator	Laparoscopic procedure: Pelvic Organs Prolapse Suspension	Procedure: Laparoscopic procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic procedure	Procedure		POPS Sacral colpopexy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with anatomical correction of the prolapse	Anatomical correction of the prolapse evaluated by gynecological visit	up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of recurrence		up to 6 months
Post operative quality of life	Subjective satisfaction of the patient evaluated by a quality of life questionnaire.	up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria:

Age > 70 years
Severe cardiovascular or respiratory disease
Pregnancy
Previous surgical procedure for POP correction

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided