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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01320215

Collaborator

(none)

364

Enrollment

Locations

Arms

146.3

Anticipated Duration (Months)

20.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Robot-assisted promontofixation Procedure: Non-robot assisted promontofixation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

364 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

Actual Study Start Date :

Jun 22, 2011

Actual Primary Completion Date :

Sep 12, 2017

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot arm The patients in this arm will have a robot-assisted promontofixation.	Procedure: Robot-assisted promontofixation Sacrohysteropexy with robotic assistance (da Vinci robot)
Active Comparator: Non-robot arm The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.	Procedure: Non-robot assisted promontofixation Laparoscopic sacrohysteropexy, without robot assistance

Arm

Intervention/Treatment

Experimental: Robot arm

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

Procedure: Robot-assisted promontofixation

Sacrohysteropexy with robotic assistance (da Vinci robot)

Active Comparator: Non-robot arm

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

Procedure: Non-robot assisted promontofixation

Laparoscopic sacrohysteropexy, without robot assistance

Outcome Measures

Primary Outcome Measures

presence/absence of complications (composite score) [30 days]
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.

Secondary Outcome Measures

Time needed to prep the operation room (min) [1 day]
length of hospital stay (days) [1 month]
The number of days the patient stays in the hospital following promontofixation
Operative time (min) [1 day]
The time elapsed between incision and closure of the patient
Anesthesia time (min) [1 day]
The time elapsed between anethesia induction and awakening
Equipment installation time (min) [1 day]
Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
Surgical time (min) [1 day]
The time spent manipulating endoscopic intruments or console time for robotic techniques.
Presence/absence of conversion [Day 1]
In the robot arm: the need to convert to laparoscopic procedure or open procedure; in the non-robot arm: the need to convert to an open procedure
presence/absence of a re-intervention [30 days]
Presence/absence of urinary incontinence [3 months]
Presence/absence of urinary incontinence [12 months]
Presence/absence of urinary incontinence [36 months]
Presence/absence of urinary incontinence [60 months]
presence/absence of constipation [3 months]
presence/absence of constipation [12 months]
presence/absence of constipation [36 months]
presence/absence of constipation [60 months]
Presence/absence of fecal incontinence [3 months]
Presence/absence of fecal incontinence [12 months]
Presence/absence of fecal incontinence [36 months]
Presence/absence of fecal incontinence [60 months]
presence/absence of dysparunia [3 months]
presence/absence of dysparunia [12 months]
presence/absence of dysparunia [36 months]
presence/absence of dysparunia [60 months]
POP-Q score [3 months]
POP-Q score [12 months]
POP-Q score [36 months]
POP-Q score [60 months]
Urodynamic exam Q max (ml/s) [3 months]
Urination rate il ml/s
Urodynamic exam Q max (ml/s) [12 months]
Urination rate il ml/s
Urodynamic exam Q max (ml/s) [36 months]
Urination rate il ml/s
Urodynamic exam Q max (ml/s) [60 months]
Urination rate il ml/s
Urodynamic exam, volume urinated (ml) [3 months]
the volume urinated in ml
Urodynamic exam, volume urinated (ml) [12 months]
the volume urinated in ml
Urodynamic exam, volume urinated (ml) [36 months]
the volume urinated in ml
Urodynamic exam, volume urinated (ml) [60 months]
the volume urinated in ml
Urodynamic exam: post-mictionnel residu (ml) [3 months]
Urodynamic exam: post-mictionnel residu (ml) [12 months]
Urodynamic exam: post-mictionnel residu (ml) [36 months]
Urodynamic exam: post-mictionnel residu (ml) [60 months]
Urodynamic exam: fonctional bladder capacity (ml) [3 months]
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml) [12 months]
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml) [36 months]
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml) [60 months]
bladder capacity in ml
Urodynamic exam: urethral closure pressure (cm water) [3 months]
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water) [12 months]
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water) [36 months]
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water) [60 months]
urethral closure pressure in cm of water
Wexner anal incontinence score [3 months]
Wexner anal incontinence score [12 months]
Wexner anal incontinence score [36 months]
Wexner anal incontinence score [60 months]
ODS constipation score [3 months]
ODS constipation score [12 months]
ODS constipation score [36 months]
ODS constipation score [60 months]
Visual analog scale for pain [day 1]
Visual analog scale for pain [day 2]
Visual analog scale for pain [day 3]
Visual analog scale for pain [day 4]
Visual analog scale for pain [3 months]
Visual analog scale for pain [12 months]
Visual analog scale for pain [36 months]
Visual analog scale for pain [60 months]
Patient satisfaction [Day 4]
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction [3 months]
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction [12 months]
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction [36 months]
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction [60 months]
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Questionnaire PFDI-20 [3 months]
Questionnaire PFDI-20 [12 months]
Questionnaire PFDI-20 [36 months]
Questionnaire PFDI-20 [60 months]
Questionnaire PFIQ-7 [3 months]
Questionnaire PFIQ-7 [12 months]
Questionnaire PFIQ-7 [36 months]
Questionnaire PFIQ-7 [60 months]
Questionnaire PISQ-12 [3 months]
Questionnaire PISQ-12 [12 months]
Questionnaire PISQ-12 [36 months]
Questionnaire PISQ-12 [60 months]
Questionnaire SF36 [3 months]
Questionnaire SF36 [12 months]
Questionnaire SF36 [36 months]
Questionnaire SF36 [60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard	France	30029
2	Groupe Urologie Saint Augustin	Bordeaux		France	33074
3	APHP - Centre Hospitalier Henri Mondor	Créteil		France	94000
4	CHU de Dijon	Dijon		France	21079
5	CHU de Montpellier - Hôpital Lapeyronie	Montpellier		France	34295
6	CHU de Nancy - Hôpitaux de Brabois	Nancy		France
7	CHU de Nantes	Nantes		France	44000
8	CHU de Nice - Hôpitaux L'Archet 1 et 2	Nice		France	06202
9	Clinique Kennedy	Nîmes		France	30900
10	Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly	Paris		France	75012
11	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris		France	75651
12	CHU de Lyon - Centre Hospitalier Lyon Sud	Pierre Benite		France	69310
13	CHU de Rennes - Hôpital PontChaillou	Rennes		France	35033
14	Clinique Belledonne	St Martin d'Héres		France	38400
15	CHRU de Strasbourg - Hôpital Civil	Strasbourg Cedex		France	67091
16	Hôpital Foch	Suresnes		France	92151
17	CHRU de Toulouse - Hôpital de Rangueil	Toulouse		France	31059
18	CHRU de Tours - Hôpital Bretonneau	Tours		France	37044