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. (see Contacts and Locations)
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: October 16, 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; 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) [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
APHP - Groupe Hospitalier Pitié-Salpetrière Recruiting
Paris, France, 75651
Sub-Investigator: Christophe Vaessen, 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         
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: October 16, 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:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014