Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures (RoboLaps)
This study is currently recruiting participants.
Verified January 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320215
First received: March 21, 2011
Last updated: April 21, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Procedure: Robot-assisted promontofixation Procedure: Non-robot assisted promontofixation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- presence/absence of complications (composite score) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Time needed to prep the operation room (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- length of hospital stay (days) [ Time Frame: 1 month ] [ Designated as safety issue: No ]The number of days the patient stays in the hospital following promontofixation
- Operative time (min) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]The time elapsed between incision and closure of the patient
- Anesthesia time (min) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]The time elapsed between anethesia induction and awakening
- Equipment installation time (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
- Surgical time (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]The time spent manipulating endoscopic intruments or console time for robotic techniques.
- Presence/absence of conversion [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Presence/absence of urinary incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Presence/absence of urinary incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Presence/absence of urinary incontinence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Presence/absence of urinary incontinence [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- presence/absence of constipation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- presence/absence of constipation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- presence/absence of constipation [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- presence/absence of constipation [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Presence/absence of fecal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Presence/absence of fecal incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Presence/absence of fecal incontinence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Presence/absence of fecal incontinence [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- presence/absence of dysparunia [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- presence/absence of dysparunia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- presence/absence of dysparunia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- presence/absence of dysparunia [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- POP-Q score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- POP-Q score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- POP-Q score [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- POP-Q score [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Urodynamic exam Q max (ml/s) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Urination rate il ml/s
- Urodynamic exam Q max (ml/s) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Urination rate il ml/s
- Urodynamic exam Q max (ml/s) [ Time Frame: 36 months ] [ Designated as safety issue: No ]Urination rate il ml/s
- Urodynamic exam Q max (ml/s) [ Time Frame: 60 months ] [ Designated as safety issue: No ]Urination rate il ml/s
- Urodynamic exam, volume urinated (ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]the volume urinated in ml
- Urodynamic exam, volume urinated (ml) [ Time Frame: 12 months ] [ Designated as safety issue: No ]the volume urinated in ml
- Urodynamic exam, volume urinated (ml) [ Time Frame: 36 months ] [ Designated as safety issue: No ]the volume urinated in ml
- Urodynamic exam, volume urinated (ml) [ Time Frame: 60 months ] [ Designated as safety issue: No ]the volume urinated in ml
- Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]bladder capacity in ml
- Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 12 months ] [ Designated as safety issue: No ]bladder capacity in ml
- Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 36 months ] [ Designated as safety issue: No ]bladder capacity in ml
- Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 60 months ] [ Designated as safety issue: No ]bladder capacity in ml
- Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 3 months ] [ Designated as safety issue: No ]urethral closure pressure in cm of water
- Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 12 months ] [ Designated as safety issue: No ]urethral closure pressure in cm of water
- Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 36 months ] [ Designated as safety issue: No ]urethral closure pressure in cm of water
- Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 60 months ] [ Designated as safety issue: No ]urethral closure pressure in cm of water
- Wexner anal incontinence score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Wexner anal incontinence score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Wexner anal incontinence score [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Wexner anal incontinence score [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- ODS constipation score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- ODS constipation score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- ODS constipation score [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- ODS constipation score [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: day 2 ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: day 3 ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: day 4 ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Visual analog scale for pain [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Patient satisfaction [ Time Frame: Day 4 ] [ Designated as safety issue: No ]Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
- Patient satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
- Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
- Patient satisfaction [ Time Frame: 36 months ] [ Designated as safety issue: No ]Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
- Patient satisfaction [ Time Frame: 60 months ] [ Designated as safety issue: No ]Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
- Questionnaire PFDI-20 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI-20 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI-20 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI-20 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ-7 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ-7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ-7 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ-7 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Questionnaire SF36 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Questionnaire SF36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire SF36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire SF36 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 364 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2020 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320215
Contacts
| Contact: Stéphane M Droupy, MD PhD | 04.66.68.32.30 | stephane.droupy@chu-nimes.fr |
| Contact: Carey M Suehs | 33466686788 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting |
| Nîmes, Gard, France, 30029 | |
| Sub-Investigator: Pierre Costa, MD PhD | |
| Principal Investigator: Stéphane Droupy, MD PhD | |
| Sub-Investigator: Laurent Wagner, MD | |
| Sub-Investigator: Laurent Soustelle, MD | |
| Sub-Investigator: Renaud de Tayrac, MD PhD | |
| Groupe Urologie Saint Augustin | Recruiting |
| Bordeaux, France, 33074 | |
| Sub-Investigator: Jean-Luc Hoepffner, MD | |
| APHP - Centre Hospitalier Henri Mondor | Recruiting |
| Créteil, France, 94000 | |
| Sub-Investigator: Alexandre Delataille, MD PhD | |
| Sub-Investigator: René Yiou, MD | |
| CHU de Dijon | Recruiting |
| Dijon, France, 21079 | |
| Sub-Investigator: Serge Douvier, MD PhD | |
| CHU de Montpellier - Hôpital Lapeyronie | Recruiting |
| Montpellier, France, 34295 | |
| Sub-Investigator: Mélanie Cayrac, MD | |
| Sub-Investigator: Laurent Cabaniols, MD | |
| CHU de Nancy - Hôpitaux de Brabois | Recruiting |
| Nancy, France | |
| Sub-Investigator: Pascal Eschwege, MD PhD | |
| Sub-Investigator: Laure Cayzergues, MD | |
| CHU de Nantes | Recruiting |
| Nantes, France, 44000 | |
| Sub-Investigator: Jérôme Rigaud, MD | |
| Sub-Investigator: Guillaume Meurette, MD | |
| Clinique Kennedy | Recruiting |
| Nîmes, France, 30900 | |
| Sub-Investigator: Pascal Volpe, MD | |
| Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly | Recruiting |
| Paris, France, 75012 | |
| Sub-Investigator: Richard Villet, MD | |
| Sub-Investigator: Etienne Vincens, MD | |
| Sub-Investigator: Pierre Gadonneix, MD | |
| Sub-Investigator: Delphine Salet-Lizée, MD | |
| Sub-Investigator: Ariane Cortesse-Lacaine, MD | |
| Sub-Investigator: Alexandre Coleau, MD | |
| Sub-Investigator: Guillonneau Bertrand, MD | |
| APHP - Groupe Hospitalier Pitié-Salpetrière | Recruiting |
| Paris, France, 75651 | |
| Sub-Investigator: Christophe Vaessen, MD | |
| CHU de Lyon - Centre Hospitalier Lyon Sud | Recruiting |
| Pierre Benite, France, 69310 | |
| Sub-Investigator: Alain Ruffion, MD, PhD | |
| CHU de Rennes - Hôpital PontChaillou | Recruiting |
| Rennes, France, 35033 | |
| Sub-Investigator: Andrea Manunta, MD | |
| Clinique Belledonne | Recruiting |
| St Martin d'Héres, France, 38400 | |
| Sub-Investigator: Pierre Monod, MD | |
| Sub-Investigator: François Muet, MD | |
| Hôpital Foch | Recruiting |
| Suresnes, France, 92151 | |
| Sub-Investigator: Thierry Lebret, MD PhD | |
| Sub-Investigator: Adrien Vidart, MD | |
| CHRU de Toulouse - Hôpital de Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Sub-Investigator: Eric Huyghe, MD | |
| Sub-Investigator: Pierre Leguevaque, MD, PhD | |
| CHRU de Tours - Hôpital Bretonneau | Recruiting |
| Tours, France, 37044 | |
| Sub-Investigator: Franck Bruyère, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Stéphane Droupy, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01320215 History of Changes |
| Other Study ID Numbers: | PHRC-N/2010/SD-01, 2010-A01110-39 |
| Study First Received: | March 21, 2011 |
| Last Updated: | April 21, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
da Vinci Robot uterine prolapse vaginal prolapse sacrohysteropexy |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013