Pelvic Organ Prolapse
Conditions
Keywords
da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy
Brief summary
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.
Interventions
PROCEDURERobot-assisted promontofixation
Sacrohysteropexy with robotic assistance (da Vinci robot)
PROCEDURENon-robot assisted promontofixation
Laparoscopic sacrohysteropexy, without robot assistance
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence/absence of complications (composite score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire PFDI-20 | 3 months | — |
| Questionnaire PFIQ-7 | 3 months | — |
| Time needed to prep the operation room (min) | 1 day | — |
| Operative time (min) | 1 day | The time elapsed between incision and closure of the patient |
| Anesthesia time (min) | 1 day | The time elapsed between anethesia induction and awakening |
| Equipment installation time (min) | 1 day | Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools) |
| Surgical time (min) | 1 day | The time spent manipulating endoscopic intruments or console time for robotic techniques. |
| Presence/absence of conversion | 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 | 30 days | — |
| Presence/absence of urinary incontinence | 3 months | — |
| presence/absence of constipation | 3 months | — |
| Presence/absence of fecal incontinence | 3 months | — |
| length of hospital stay (days) | 1 month | The number of days the patient stays in the hospital following promontofixation |
| POP-Q score | 3 months | — |
| Urodynamic exam Q max (ml/s) | 3 months | Urination rate il ml/s |
| Urodynamic exam, volume urinated (ml) | 3 months | the volume urinated in ml |
| Urodynamic exam: post-mictionnel residu (ml) | 3 months | — |
| Urodynamic exam: fonctional bladder capacity (ml) | 3 months | bladder capacity in ml |
| Urodynamic exam: urethral closure pressure (cm water) | 3 months | urethral closure pressure in cm of water |
| Wexner anal incontinence score | 3 months | — |
| ODS constipation score | 3 months | — |
| Visual analog scale for pain | day 1 | — |
| Patient satisfaction | Day 4 | Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure? |
| Questionnaire PISQ-12 | 3 months | — |
| Questionnaire SF36 | 3 months | — |
| presence/absence of dysparunia | 3 months | — |
Countries
France
Outcome results
None listed