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

Study Overview
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Brief Summary
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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. The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

Official Title
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Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Robot-assisted promontofixation
* Procedure: Non-robot assisted promontofixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot arm<br>The patients in this arm will have a robot-assisted promontofixation. | Procedure: Robot-assisted promontofixation<br>* Sacrohysteropexy with robotic assistance (da Vinci robot)<br>|
| Active Comparator: Non-robot arm<br>The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance. | Procedure: Non-robot assisted promontofixation<br>* Laparoscopic sacrohysteropexy, without robot assistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence/absence of complications (composite score) | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to prep the operation room (min) |  | 1 day | 
| length of hospital stay (days) | The number of days the patient stays in the hospital following promontofixation | 1 month | 
| Operative time (min) | The time elapsed between incision and closure of the patient | 1 day | 
| Anesthesia time (min) | The time elapsed between anethesia induction and awakening | 1 day | 
| Equipment installation time (min) | Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools) | 1 day | 
| Surgical time (min) | The time spent manipulating endoscopic intruments or console time for robotic techniques. | 1 day | 
| Presence/absence of conversion | 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 | Day 1 | 
| presence/absence of a re-intervention |  | 30 days | 
| Presence/absence of urinary incontinence |  | 3 months | 
| Presence/absence of urinary incontinence |  | 12 months | 
| Presence/absence of urinary incontinence |  | 36 months | 
| Presence/absence of urinary incontinence |  | 60 months | 
| presence/absence of constipation |  | 3 months | 
| presence/absence of constipation |  | 12 months | 
| presence/absence of constipation |  | 36 months | 
| presence/absence of constipation |  | 60 months | 
| Presence/absence of fecal incontinence |  | 3 months | 
| Presence/absence of fecal incontinence |  | 12 months | 
| Presence/absence of fecal incontinence |  | 36 months | 
| Presence/absence of fecal incontinence |  | 60 months | 
| presence/absence of dysparunia |  | 3 months | 
| presence/absence of dysparunia |  | 12 months | 
| presence/absence of dysparunia |  | 36 months | 
| presence/absence of dysparunia |  | 60 months | 
| POP-Q score |  | 3 months | 
| POP-Q score |  | 12 months | 
| POP-Q score |  | 36 months | 
| POP-Q score |  | 60 months | 
| Urodynamic exam Q max (ml/s) | Urination rate il ml/s | 3 months | 
| Urodynamic exam Q max (ml/s) | Urination rate il ml/s | 12 months | 
| Urodynamic exam Q max (ml/s) | Urination rate il ml/s | 36 months | 
| Urodynamic exam Q max (ml/s) | Urination rate il ml/s | 60 months | 
| Urodynamic exam, volume urinated (ml) | the volume urinated in ml | 3 months | 
| Urodynamic exam, volume urinated (ml) | the volume urinated in ml | 12 months | 
| Urodynamic exam, volume urinated (ml) | the volume urinated in ml | 36 months | 
| Urodynamic exam, volume urinated (ml) | the volume urinated in ml | 60 months | 
| Urodynamic exam: post-mictionnel residu (ml) |  | 3 months | 
| Urodynamic exam: post-mictionnel residu (ml) |  | 12 months | 
| Urodynamic exam: post-mictionnel residu (ml) |  | 36 months | 
| Urodynamic exam: post-mictionnel residu (ml) |  | 60 months | 
| Urodynamic exam: fonctional bladder capacity (ml) | bladder capacity in ml | 3 months | 
| Urodynamic exam: fonctional bladder capacity (ml) | bladder capacity in ml | 12 months | 
| Urodynamic exam: fonctional bladder capacity (ml) | bladder capacity in ml | 36 months | 
| Urodynamic exam: fonctional bladder capacity (ml) | bladder capacity in ml | 60 months | 
| Urodynamic exam: urethral closure pressure (cm water) | urethral closure pressure in cm of water | 3 months | 
| Urodynamic exam: urethral closure pressure (cm water) | urethral closure pressure in cm of water | 12 months | 
| Urodynamic exam: urethral closure pressure (cm water) | urethral closure pressure in cm of water | 36 months | 
| Urodynamic exam: urethral closure pressure (cm water) | urethral closure pressure in cm of water | 60 months | 
| Wexner anal incontinence score |  | 3 months | 
| Wexner anal incontinence score |  | 12 months | 
| Wexner anal incontinence score |  | 36 months | 
| Wexner anal incontinence score |  | 60 months | 
| ODS constipation score |  | 3 months | 
| ODS constipation score |  | 12 months | 
| ODS constipation score |  | 36 months | 
| ODS constipation score |  | 60 months | 
| Visual analog scale for pain |  | day 1 | 
| Visual analog scale for pain |  | day 2 | 
| Visual analog scale for pain |  | day 3 | 
| Visual analog scale for pain |  | day 4 | 
| Visual analog scale for pain |  | 3 months | 
| Visual analog scale for pain |  | 12 months | 
| Visual analog scale for pain |  | 36 months | 
| Visual analog scale for pain |  | 60 months | 
| Patient satisfaction | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? | Day 4 | 
| Patient satisfaction | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? | 3 months | 
| Patient satisfaction | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? | 12 months | 
| Patient satisfaction | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? | 36 months | 
| Patient satisfaction | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? | 60 months | 
| Questionnaire PFDI-20 |  | 3 months | 
| Questionnaire PFDI-20 |  | 12 months | 
| Questionnaire PFDI-20 |  | 36 months | 
| Questionnaire PFDI-20 |  | 60 months | 
| Questionnaire PFIQ-7 |  | 3 months | 
| Questionnaire PFIQ-7 |  | 12 months | 
| Questionnaire PFIQ-7 |  | 36 months | 
| Questionnaire PFIQ-7 |  | 60 months | 
| Questionnaire PISQ-12 |  | 3 months | 
| Questionnaire PISQ-12 |  | 12 months | 
| Questionnaire PISQ-12 |  | 36 months | 
| Questionnaire PISQ-12 |  | 60 months | 
| Questionnaire SF36 |  | 3 months | 
| Questionnaire SF36 |  | 12 months | 
| Questionnaire SF36 |  | 36 months | 
| Questionnaire SF36 |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy