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Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Primary Purpose

Rectal Prolapse, Pelvic Organ Prolapse

Status

Unknown status

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Minimally invasive rectopexy

About this trial

This is an interventional treatment trial for Rectal Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

women
proven pelvic floor dysfunction
informed consent

Exclusion Criteria:

Age <18 years old
Patient unable to communicate or to understand the study
Patient refusing to participate to the study
contraindication to laparoscopy

Sites / Locations

University Hospital of Geneva, Department of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Robotic

Laparoscopy

Arm Description

Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction

Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction

Outcomes

Primary Outcome Measures

Perioperative outcomes

Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.

Secondary Outcome Measures

Functional results

Constipation score Incontinence score Quality of life score Sexuality score

Full Information

NCT ID

NCT01346436

First Posted

April 29, 2011

Last Updated

May 4, 2017

Sponsor

Nicolas C. Buchs

1. Study Identification

Unique Protocol Identification Number

NCT01346436

Brief Title

Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Official Title

Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nicolas C. Buchs

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.

Detailed Description

Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease. Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published. However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery. Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded. The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Prolapse, Pelvic Organ Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic

Arm Type

Active Comparator

Arm Description

Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction

Arm Title

Laparoscopy

Arm Type

Active Comparator

Arm Description

Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction

Intervention Type

Procedure

Intervention Name(s)

Minimally invasive rectopexy

Other Intervention Name(s)

Surgery for rectal prolapse

Intervention Description

Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Primary Outcome Measure Information:

Title

Perioperative outcomes

Description

Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.

Time Frame

up to 30 days

Secondary Outcome Measure Information:

Title

Functional results

Description

Constipation score Incontinence score Quality of life score Sexuality score

Time Frame

At 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: women proven pelvic floor dysfunction informed consent Exclusion Criteria: Age <18 years old Patient unable to communicate or to understand the study Patient refusing to participate to the study contraindication to laparoscopy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas C Buchs, MD

Phone

+41 79 553 2683

nicolas.c.buchs@hcuge.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas C Buchs, MD

Organizational Affiliation

University Hospital, Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Geneva, Department of Surgery

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas C Buchs, MD

Phone

+41 553 2683

nicolas.c.buchs@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Nicolas C Buchs, MD

First Name & Middle Initial & Last Name & Degree

Bruno Roche, MD

First Name & Middle Initial & Last Name & Degree

François Pugin, MD

First Name & Middle Initial & Last Name & Degree

Pascal Bucher, MD

First Name & Middle Initial & Last Name & Degree

Karel Skala, MD

First Name & Middle Initial & Last Name & Degree

Frédéric Ris, MD

First Name & Middle Initial & Last Name & Degree

Monika Hagen, MD

First Name & Middle Initial & Last Name & Degree

Guillaume Zufferey, MD

First Name & Middle Initial & Last Name & Degree

Philippe Morel, MD

12. IPD Sharing Statement

Learn more about this trial

Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

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