Clinical trial NCT01320215: Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Official title: Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: da Vinci Robot
uterine prolapse
vaginal prolapse
sacrohysteropexy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 365
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility 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

Primary outcomes:
measure: presence/absence of complications (composite score)
timeFrame: 30 days
Secondary outcomes:
measure: Time needed to prep the operation room (min)
timeFrame: 1 day
measure: length of hospital stay (days)
timeFrame: 1 month
measure: Operative time (min)
timeFrame: 1 day
measure: Anesthesia time (min)
timeFrame: 1 day
measure: Equipment installation time (min)
timeFrame: 1 day
measure: Surgical time (min)
timeFrame: 1 day
measure: Presence/absence of conversion
timeFrame: Day 1
measure: presence/absence of a re-intervention
timeFrame: 30 days
measure: Presence/absence of urinary incontinence
timeFrame: 3 months
measure: Presence/absence of urinary incontinence
timeFrame: 12 months
measure: Presence/absence of urinary incontinence
timeFrame: 36 months
measure: Presence/absence of urinary incontinence
timeFrame: 60 months
measure: presence/absence of constipation
timeFrame: 3 months
measure: presence/absence of constipation
timeFrame: 12 months
measure: presence/absence of constipation
timeFrame: 36 months
measure: presence/absence of constipation
timeFrame: 60 months
measure: Presence/absence of fecal incontinence
timeFrame: 3 months
measure: Presence/absence of fecal incontinence
timeFrame: 12 months
measure: Presence/absence of fecal incontinence
timeFrame: 36 months
measure: Presence/absence of fecal incontinence
timeFrame: 60 months
measure: presence/absence of dysparunia
timeFrame: 3 months
measure: presence/absence of dysparunia
timeFrame: 12 months
measure: presence/absence of dysparunia
timeFrame: 36 months
measure: presence/absence of dysparunia
timeFrame: 60 months
measure: POP-Q score
timeFrame: 3 months
measure: POP-Q score
timeFrame: 12 months
measure: POP-Q score
timeFrame: 36 months
measure: POP-Q score
timeFrame: 60 months
measure: Urodynamic exam Q max (ml/s)
timeFrame: 3 months
measure: Urodynamic exam Q max (ml/s)
timeFrame: 12 months
measure: Urodynamic exam Q max (ml/s)
timeFrame: 36 months
measure: Urodynamic exam Q max (ml/s)
timeFrame: 60 months
measure: Urodynamic exam, volume urinated (ml)
timeFrame: 3 months
measure: Urodynamic exam, volume urinated (ml)
timeFrame: 12 months
measure: Urodynamic exam, volume urinated (ml)
timeFrame: 36 months
measure: Urodynamic exam, volume urinated (ml)
timeFrame: 60 months
measure: Urodynamic exam: post-mictionnel residu (ml)
timeFrame: 3 months
measure: Urodynamic exam: post-mictionnel residu (ml)
timeFrame: 12 months
measure: Urodynamic exam: post-mictionnel residu (ml)
timeFrame: 36 months
measure: Urodynamic exam: post-mictionnel residu (ml)
timeFrame: 60 months
measure: Urodynamic exam: fonctional bladder capacity (ml)
timeFrame: 3 months
measure: Urodynamic exam: fonctional bladder capacity (ml)
timeFrame: 12 months
measure: Urodynamic exam: fonctional bladder capacity (ml)
timeFrame: 36 months
measure: Urodynamic exam: fonctional bladder capacity (ml)
timeFrame: 60 months
measure: Urodynamic exam: urethral closure pressure (cm water)
timeFrame: 3 months
measure: Urodynamic exam: urethral closure pressure (cm water)
timeFrame: 12 months
measure: Urodynamic exam: urethral closure pressure (cm water)
timeFrame: 36 months
measure: Urodynamic exam: urethral closure pressure (cm water)
timeFrame: 60 months
measure: Wexner anal incontinence score
timeFrame: 3 months
measure: Wexner anal incontinence score
timeFrame: 12 months
measure: Wexner anal incontinence score
timeFrame: 36 months
measure: Wexner anal incontinence score
timeFrame: 60 months
measure: ODS constipation score
timeFrame: 3 months
measure: ODS constipation score
timeFrame: 12 months
measure: ODS constipation score
timeFrame: 36 months
measure: ODS constipation score
timeFrame: 60 months
measure: Visual analog scale for pain
timeFrame: day 1
measure: Visual analog scale for pain
timeFrame: day 2
measure: Visual analog scale for pain
timeFrame: day 3
measure: Visual analog scale for pain
timeFrame: day 4
measure: Visual analog scale for pain
timeFrame: 3 months
measure: Visual analog scale for pain
timeFrame: 12 months
measure: Visual analog scale for pain
timeFrame: 36 months
measure: Visual analog scale for pain
timeFrame: 60 months
measure: Patient satisfaction
timeFrame: Day 4
measure: Patient satisfaction
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 36 months
measure: Patient satisfaction
timeFrame: 60 months
measure: Questionnaire PFDI-20
timeFrame: 3 months
measure: Questionnaire PFDI-20
timeFrame: 12 months
measure: Questionnaire PFDI-20
timeFrame: 36 months
measure: Questionnaire PFDI-20
timeFrame: 60 months
measure: Questionnaire PFIQ-7
timeFrame: 3 months
measure: Questionnaire PFIQ-7
timeFrame: 12 months
measure: Questionnaire PFIQ-7
timeFrame: 36 months
measure: Questionnaire PFIQ-7
timeFrame: 60 months
measure: Questionnaire PISQ-12
timeFrame: 3 months
measure: Questionnaire PISQ-12
timeFrame: 12 months
measure: Questionnaire PISQ-12
timeFrame: 36 months
measure: Questionnaire PISQ-12
timeFrame: 60 months
measure: Questionnaire SF36
timeFrame: 3 months
measure: Questionnaire SF36
timeFrame: 12 months
measure: Questionnaire SF36
timeFrame: 36 months
measure: Questionnaire SF36
timeFrame: 60 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Bordeaux
country: France
facility: Groupe Urologie Saint Augustin
city: Créteil
country: France
facility: APHP - Centre Hospitalier Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nancy
country: France
facility: CHU de Nancy - Hôpitaux de Brabois
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice - Hôpitaux L'Archet 1 et 2
city: Nîmes
country: France
facility: Clinique Kennedy
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
city: Paris
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Pierre Benite
country: France
facility: CHU de Lyon - Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHU de Rennes - Hôpital PontChaillou
city: St Martin d'Héres
country: France
facility: Clinique Belledonne
city: Strasbourg Cedex
country: France
facility: CHRU de Strasbourg - Hôpital Civil
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Droupy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: