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

• 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 ]

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.

• 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

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