Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatments robot-assisted promontofixation, non-robot assisted promontofixation
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date June 2011
End date October 2016
Trial size 364 participants
Trial identifier NCT01320215, 2010-A01110-39, PHRC-N/2010/SD-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
The patients in this arm will have a robot-assisted promontofixation.
robot-assisted promontofixation
Sacrohysteropexy with robotic assistance (da Vinci robot)
(Active Comparator)
The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.
non-robot assisted promontofixation
Laparoscopic sacrohysteropexy, without robot assistance

Primary Outcomes

Measure
presence/absence of complications (composite score)
time frame: 30 days

Secondary Outcomes

Measure
Time needed to prep the operation room (min)
time frame: 1 day
length of hospital stay (days)
time frame: 1 month
Operative time (min)
time frame: 1 day
Anesthesia time (min)
time frame: 1 day
Equipment installation time (min)
time frame: 1 day
Surgical time (min)
time frame: 1 day
Presence/absence of conversion
time frame: Day 1
presence/absence of a re-intervention
time frame: 30 days
Presence/absence of urinary incontinence
time frame: 3 months
Presence/absence of urinary incontinence
time frame: 12 months
Presence/absence of urinary incontinence
time frame: 36 months
Presence/absence of urinary incontinence
time frame: 60 months
presence/absence of constipation
time frame: 3 months
presence/absence of constipation
time frame: 12 months
presence/absence of constipation
time frame: 36 months
presence/absence of constipation
time frame: 60 months
Presence/absence of fecal incontinence
time frame: 3 months
Presence/absence of fecal incontinence
time frame: 12 months
Presence/absence of fecal incontinence
time frame: 36 months
Presence/absence of fecal incontinence
time frame: 60 months
presence/absence of dysparunia
time frame: 3 months
presence/absence of dysparunia
time frame: 12 months
presence/absence of dysparunia
time frame: 36 months
presence/absence of dysparunia
time frame: 60 months
POP-Q score
time frame: 3 months
POP-Q score
time frame: 12 months
POP-Q score
time frame: 36 months
POP-Q score
time frame: 60 months
Urodynamic exam Q max (ml/s)
time frame: 3 months
Urodynamic exam Q max (ml/s)
time frame: 12 months
Urodynamic exam Q max (ml/s)
time frame: 36 months
Urodynamic exam Q max (ml/s)
time frame: 60 months
Urodynamic exam, volume urinated (ml)
time frame: 3 months
Urodynamic exam, volume urinated (ml)
time frame: 12 months
Urodynamic exam, volume urinated (ml)
time frame: 36 months
Urodynamic exam, volume urinated (ml)
time frame: 60 months
Urodynamic exam: post-mictionnel residu (ml)
time frame: 3 months
Urodynamic exam: post-mictionnel residu (ml)
time frame: 12 months
Urodynamic exam: post-mictionnel residu (ml)
time frame: 36 months
Urodynamic exam: post-mictionnel residu (ml)
time frame: 60 months
Urodynamic exam: fonctional bladder capacity (ml)
time frame: 3 months
Urodynamic exam: fonctional bladder capacity (ml)
time frame: 12 months
Urodynamic exam: fonctional bladder capacity (ml)
time frame: 36 months
Urodynamic exam: fonctional bladder capacity (ml)
time frame: 60 months
Urodynamic exam: urethral closure pressure (cm water)
time frame: 3 months
Urodynamic exam: urethral closure pressure (cm water)
time frame: 12 months
Urodynamic exam: urethral closure pressure (cm water)
time frame: 36 months
Urodynamic exam: urethral closure pressure (cm water)
time frame: 60 months
Wexner anal incontinence score
time frame: 3 months
Wexner anal incontinence score
time frame: 12 months
Wexner anal incontinence score
time frame: 36 months
Wexner anal incontinence score
time frame: 60 months
ODS constipation score
time frame: 3 months
ODS constipation score
time frame: 12 months
ODS constipation score
time frame: 36 months
ODS constipation score
time frame: 60 months
Visual analog scale for pain
time frame: day 1
Visual analog scale for pain
time frame: day 2
Visual analog scale for pain
time frame: day 3
Visual analog scale for pain
time frame: day 4
Visual analog scale for pain
time frame: 3 months
Visual analog scale for pain
time frame: 12 months
Visual analog scale for pain
time frame: 36 months
Visual analog scale for pain
time frame: 60 months
Patient satisfaction
time frame: Day 4
Patient satisfaction
time frame: 3 months
Patient satisfaction
time frame: 12 months
Patient satisfaction
time frame: 36 months
Patient satisfaction
time frame: 60 months
Questionnaire PFDI-20
time frame: 3 months
Questionnaire PFDI-20
time frame: 12 months
Questionnaire PFDI-20
time frame: 36 months
Questionnaire PFDI-20
time frame: 60 months
Questionnaire PFIQ-7
time frame: 3 months
Questionnaire PFIQ-7
time frame: 12 months
Questionnaire PFIQ-7
time frame: 36 months
Questionnaire PFIQ-7
time frame: 60 months
Questionnaire PISQ-12
time frame: 3 months
Questionnaire PISQ-12
time frame: 12 months
Questionnaire PISQ-12
time frame: 36 months
Questionnaire PISQ-12
time frame: 60 months
Questionnaire SF36
time frame: 3 months
Questionnaire SF36
time frame: 12 months
Questionnaire SF36
time frame: 36 months
Questionnaire SF36
time frame: 60 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Principal investigator Stéphane Droupy, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.