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

Nicolas C. Buchs

Status and phase: Unknown; Phase 4

Conditions: Rectal Prolapse; Pelvic Organ Prolapse

Treatments: Procedure: Minimally invasive rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01346436

CER-11-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Robotic

Active Comparator group

Description:

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

Treatment:

Procedure: Minimally invasive rectopexy

Laparoscopy

Active Comparator group

Description:

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

Treatment:

Procedure: Minimally invasive rectopexy