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 March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320215
First received: March 21, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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: March 4, 2014
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 April 22, 2014