NCT01346436

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

9.1 years

First QC Date

April 29, 2011

Last Update Submit

May 4, 2017

Conditions

Rectal ProlapsePelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Perioperative outcomes

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

    up to 30 days

Secondary Outcomes (1)

  • Functional results

    At 12 months

Study Arms (2)

Robotic

ACTIVE COMPARATOR

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

Procedure: Minimally invasive rectopexy

Laparoscopy

ACTIVE COMPARATOR

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

Procedure: Minimally invasive rectopexy

Interventions

Minimally invasive rectopexyPROCEDURE

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

Also known as: Surgery for rectal prolapse
LaparoscopyRobotic

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women
  • proven pelvic floor dysfunction
  • informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva, Department of Surgery

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Rectal ProlapsePelvic Organ Prolapse

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas C Buchs, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas C Buchs, MD

CONTACT

+41 79 553 2683nicolas.c.buchs@hcuge.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty surgeon

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 3, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

CH(1)