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Register:	ClinicalTrials.gov
Last refreshed on:	30 October 2023
Main ID:	NCT01320215
Date of registration:	21/03/2011
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures RoboLaps
Scientific title:	Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Date of first enrolment:	June 22, 2011
Target sample size:	365
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT01320215
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Stéphane Droupy, MD PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Organ Prolapse

Intervention(s)

Procedure: Robot-assisted promontofixation

Procedure: Non-robot assisted promontofixation

Primary Outcome(s)

presence/absence of complications (composite score) [Time Frame: 30 days]

Secondary Outcome(s)

POP-Q score [Time Frame: 3 months]

presence/absence of constipation [Time Frame: 12 months]

Questionnaire PFIQ-7 [Time Frame: 3 months]

Questionnaire PFIQ-7 [Time Frame: 36 months]

Questionnaire PISQ-12 [Time Frame: 36 months]

Questionnaire PISQ-12 [Time Frame: 60 months]

Urodynamic exam: fonctional bladder capacity (ml) [Time Frame: 36 months]

Urodynamic exam: fonctional bladder capacity (ml) [Time Frame: 60 months]

Urodynamic exam: post-mictionnel residu (ml) [Time Frame: 12 months]

Visual analog scale for pain [Time Frame: 36 months]

Anesthesia time (min) [Time Frame: 1 day]

ODS constipation score [Time Frame: 12 months]

Visual analog scale for pain [Time Frame: 60 months]

Visual analog scale for pain [Time Frame: day 4]

Questionnaire PFDI-20 [Time Frame: 3 months]

Questionnaire PISQ-12 [Time Frame: 3 months]

Patient satisfaction [Time Frame: Day 4]

POP-Q score [Time Frame: 12 months]

POP-Q score [Time Frame: 36 months]

POP-Q score [Time Frame: 60 months]

Presence/absence of fecal incontinence [Time Frame: 3 months]

Questionnaire SF36 [Time Frame: 12 months]

Urodynamic exam Q max (ml/s) [Time Frame: 3 months]

presence/absence of a re-intervention [Time Frame: 30 days]

presence/absence of dysparunia [Time Frame: 12 months]

Patient satisfaction [Time Frame: 36 months]

Patient satisfaction [Time Frame: 60 months]

Urodynamic exam Q max (ml/s) [Time Frame: 36 months]

Urodynamic exam: urethral closure pressure (cm water) [Time Frame: 3 months]

presence/absence of constipation [Time Frame: 36 months]

presence/absence of constipation [Time Frame: 60 months]

Presence/absence of conversion [Time Frame: Day 1]

presence/absence of dysparunia [Time Frame: 36 months]

Equipment installation time (min) [Time Frame: 1 day]

ODS constipation score [Time Frame: 3 months]

presence/absence of constipation [Time Frame: 3 months]

presence/absence of dysparunia [Time Frame: 3 months]

Operative time (min) [Time Frame: 1 day]

Patient satisfaction [Time Frame: 12 months]

presence/absence of dysparunia [Time Frame: 60 months]

Questionnaire PFDI-20 [Time Frame: 36 months]

Presence/absence of urinary incontinence [Time Frame: 3 months]

Urodynamic exam: post-mictionnel residu (ml) [Time Frame: 3 months]

Presence/absence of fecal incontinence [Time Frame: 36 months]

Presence/absence of fecal incontinence [Time Frame: 60 months]

Urodynamic exam: post-mictionnel residu (ml) [Time Frame: 36 months]

Urodynamic exam: post-mictionnel residu (ml) [Time Frame: 60 months]

Wexner anal incontinence score [Time Frame: 3 months]

Visual analog scale for pain [Time Frame: 12 months]

Presence/absence of urinary incontinence [Time Frame: 12 months]

Questionnaire SF36 [Time Frame: 3 months]

Questionnaire PFIQ-7 [Time Frame: 60 months]

Questionnaire SF36 [Time Frame: 36 months]

Questionnaire PFDI-20 [Time Frame: 60 months]

Questionnaire PFIQ-7 [Time Frame: 12 months]

Questionnaire PFDI-20 [Time Frame: 12 months]

Questionnaire PISQ-12 [Time Frame: 12 months]

Questionnaire SF36 [Time Frame: 60 months]

Surgical time (min) [Time Frame: 1 day]

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: 36 months]

Urodynamic exam, volume urinated (ml) [Time Frame: 60 months]

Urodynamic exam: urethral closure pressure (cm water) [Time Frame: 36 months]

Urodynamic exam: urethral closure pressure (cm water) [Time Frame: 60 months]

Urodynamic exam, volume urinated (ml) [Time Frame: 12 months]

Visual analog scale for pain [Time Frame: 3 months]

Urodynamic exam: fonctional bladder capacity (ml) [Time Frame: 12 months]

Visual analog scale for pain [Time Frame: day 3]

Wexner anal incontinence score [Time Frame: 36 months]

Visual analog scale for pain [Time Frame: day 1]

Visual analog scale for pain [Time Frame: day 2]

length of hospital stay (days) [Time Frame: 1 month]

ODS constipation score [Time Frame: 36 months]

Wexner anal incontinence score [Time Frame: 60 months]

ODS constipation score [Time Frame: 60 months]

Patient satisfaction [Time Frame: 3 months]

Presence/absence of fecal incontinence [Time Frame: 12 months]

Presence/absence of urinary incontinence [Time Frame: 36 months]

Presence/absence of urinary incontinence [Time Frame: 60 months]

Time needed to prep the operation room (min) [Time Frame: 1 day]

Urodynamic exam Q max (ml/s) [Time Frame: 12 months]

Urodynamic exam: fonctional bladder capacity (ml) [Time Frame: 3 months]

Urodynamic exam: urethral closure pressure (cm water) [Time Frame: 12 months]

Wexner anal incontinence score [Time Frame: 12 months]

Secondary ID(s)

2010-A01110-39

PHRC-N/2010/SD-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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