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

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ClinicalTrials.gov Identifier: NCT01320215
Recruitment Status : Active, not recruiting
First Posted : March 22, 2011
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

March 21, 2011
March 22, 2011
January 31, 2017
June 2011
September 12, 2017   (Final data collection date for primary outcome measure)
presence/absence of complications (composite score) [ Time Frame: 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.
presence/absence of complications (composite score) [ Time Frame: 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.
Complete list of historical versions of study NCT01320215 on ClinicalTrials.gov Archive Site
  • Time needed to prep the operation room (min) [ Time Frame: 1 day ]
  • length of hospital stay (days) [ Time Frame: 1 month ]
    The number of days the patient stays in the hospital following promontofixation
  • Operative time (min) [ Time Frame: 1 day ]
    The time elapsed between incision and closure of the patient
  • Anesthesia time (min) [ Time Frame: 1 day ]
    The time elapsed between anethesia induction and awakening
  • Equipment installation time (min) [ Time Frame: 1 day ]
    Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
  • Surgical time (min) [ Time Frame: 1 day ]
    The time spent manipulating endoscopic intruments or console time for robotic techniques.
  • Presence/absence of conversion [ Time Frame: 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 [ Time Frame: 30 days ]
  • Presence/absence of urinary incontinence [ Time Frame: 3 months ]
  • Presence/absence of urinary incontinence [ Time Frame: 12 months ]
  • Presence/absence of urinary incontinence [ Time Frame: 36 months ]
  • Presence/absence of urinary incontinence [ Time Frame: 60 months ]
  • presence/absence of constipation [ Time Frame: 3 months ]
  • presence/absence of constipation [ Time Frame: 12 months ]
  • presence/absence of constipation [ Time Frame: 36 months ]
  • presence/absence of constipation [ Time Frame: 60 months ]
  • Presence/absence of fecal incontinence [ Time Frame: 3 months ]
  • Presence/absence of fecal incontinence [ Time Frame: 12 months ]
  • Presence/absence of fecal incontinence [ Time Frame: 36 months ]
  • Presence/absence of fecal incontinence [ Time Frame: 60 months ]
  • presence/absence of dysparunia [ Time Frame: 3 months ]
  • presence/absence of dysparunia [ Time Frame: 12 months ]
  • presence/absence of dysparunia [ Time Frame: 36 months ]
  • presence/absence of dysparunia [ Time Frame: 60 months ]
  • POP-Q score [ Time Frame: 3 months ]
  • POP-Q score [ Time Frame: 12 months ]
  • POP-Q score [ Time Frame: 36 months ]
  • POP-Q score [ Time Frame: 60 months ]
  • Urodynamic exam Q max (ml/s) [ Time Frame: 3 months ]
    Urination rate il ml/s
  • Urodynamic exam Q max (ml/s) [ Time Frame: 12 months ]
    Urination rate il ml/s
  • Urodynamic exam Q max (ml/s) [ Time Frame: 36 months ]
    Urination rate il ml/s
  • Urodynamic exam Q max (ml/s) [ Time Frame: 60 months ]
    Urination rate il ml/s
  • Urodynamic exam, volume urinated (ml) [ Time Frame: 3 months ]
    the volume urinated in ml
  • Urodynamic exam, volume urinated (ml) [ Time Frame: 12 months ]
    the volume urinated in ml
  • Urodynamic exam, volume urinated (ml) [ Time Frame: 36 months ]
    the volume urinated in ml
  • Urodynamic exam, volume urinated (ml) [ Time Frame: 60 months ]
    the volume urinated in ml
  • Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 3 months ]
  • Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 12 months ]
  • Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 36 months ]
  • Urodynamic exam: post-mictionnel residu (ml) [ Time Frame: 60 months ]
  • Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 3 months ]
    bladder capacity in ml
  • Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 12 months ]
    bladder capacity in ml
  • Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 36 months ]
    bladder capacity in ml
  • Urodynamic exam: fonctional bladder capacity (ml) [ Time Frame: 60 months ]
    bladder capacity in ml
  • Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 3 months ]
    urethral closure pressure in cm of water
  • Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 12 months ]
    urethral closure pressure in cm of water
  • Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 36 months ]
    urethral closure pressure in cm of water
  • Urodynamic exam: urethral closure pressure (cm water) [ Time Frame: 60 months ]
    urethral closure pressure in cm of water
  • Wexner anal incontinence score [ Time Frame: 3 months ]
  • Wexner anal incontinence score [ Time Frame: 12 months ]
  • Wexner anal incontinence score [ Time Frame: 36 months ]
  • Wexner anal incontinence score [ Time Frame: 60 months ]
  • ODS constipation score [ Time Frame: 3 months ]
  • ODS constipation score [ Time Frame: 12 months ]
  • ODS constipation score [ Time Frame: 36 months ]
  • ODS constipation score [ Time Frame: 60 months ]
  • Visual analog scale for pain [ Time Frame: day 1 ]
  • Visual analog scale for pain [ Time Frame: day 2 ]
  • Visual analog scale for pain [ Time Frame: day 3 ]
  • Visual analog scale for pain [ Time Frame: day 4 ]
  • Visual analog scale for pain [ Time Frame: 3 months ]
  • Visual analog scale for pain [ Time Frame: 12 months ]
  • Visual analog scale for pain [ Time Frame: 36 months ]
  • Visual analog scale for pain [ Time Frame: 60 months ]
  • Patient satisfaction [ Time Frame: Day 4 ]
    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
  • Patient satisfaction [ Time Frame: 3 months ]
    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
  • Patient satisfaction [ Time Frame: 12 months ]
    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
  • Patient satisfaction [ Time Frame: 36 months ]
    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
  • Patient satisfaction [ Time Frame: 60 months ]
    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
  • Questionnaire PFDI-20 [ Time Frame: 3 months ]
  • Questionnaire PFDI-20 [ Time Frame: 12 months ]
  • Questionnaire PFDI-20 [ Time Frame: 36 months ]
  • Questionnaire PFDI-20 [ Time Frame: 60 months ]
  • Questionnaire PFIQ-7 [ Time Frame: 3 months ]
  • Questionnaire PFIQ-7 [ Time Frame: 12 months ]
  • Questionnaire PFIQ-7 [ Time Frame: 36 months ]
  • Questionnaire PFIQ-7 [ Time Frame: 60 months ]
  • Questionnaire PISQ-12 [ Time Frame: 3 months ]
  • Questionnaire PISQ-12 [ Time Frame: 12 months ]
  • Questionnaire PISQ-12 [ Time Frame: 36 months ]
  • Questionnaire PISQ-12 [ Time Frame: 60 months ]
  • Questionnaire SF36 [ Time Frame: 3 months ]
  • Questionnaire SF36 [ Time Frame: 12 months ]
  • Questionnaire SF36 [ Time Frame: 36 months ]
  • Questionnaire SF36 [ Time Frame: 60 months ]
Same as current
Not Provided
Not Provided
 
Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Pelvic Organ Prolapse
  • Procedure: Robot-assisted promontofixation
    Sacrohysteropexy with robotic assistance (da Vinci robot)
  • Procedure: Non-robot assisted promontofixation
    Laparoscopic sacrohysteropexy, without robot assistance
  • Experimental: Robot arm
    The patients in this arm will have a robot-assisted promontofixation.
    Intervention: Procedure: Robot-assisted promontofixation
  • Active Comparator: Non-robot arm
    The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.
    Intervention: Procedure: Non-robot assisted promontofixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
364
Same as current
September 2021
September 12, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01320215
PHRC-N/2010/SD-01
2010-A01110-39 ( Other Identifier: RCB number )
Yes
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP