Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures (RoboLaps)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Robot-assisted promontofixation; Procedure: Non-robot assisted promontofixation

Study type: Interventional

Funder types: Other

Identifiers

NCT01320215

2010-A01110-39 (Other Identifier)

PHRC-N/2010/SD-01

Details and patient eligibility

About

The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques.

The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

Enrollment: 365 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery
• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 60 months of follow-up

Exclusion criteria

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant
• Patient has a stage-1 prolapse (POP-Q classification)
• Patient has asymptomatic prolapse
• The patient has a prolapse recurrence (i.e. this is not the first case of prolapse)
• The patient is not available for 60 months of follow-up
• Patient has a vaginal or urinary infection
• Patient has poorly-adjusted diabetes
• Patient on long-term corticotherapy
• Patient has previously had pelvic radiotherapy
• Patient has contraindication for anesthesia
• Patient has an intestinal inflammatory disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

365 participants in 2 patient groups

Robot arm

Experimental group

Description:

The patients in this arm will have a robot-assisted promontofixation.

Treatment:

Procedure: Robot-assisted promontofixation

Non-robot arm

Active Comparator group

Description:

The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.

Treatment:

Procedure: Non-robot assisted promontofixation