Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

Study Overview
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Brief Summary
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The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.

Detailed Description
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Female pelvic floor disorders rank amongst the most common disorders affecting women and include conditions such as urinary incontinence and pelvic organ prolapse (POP). POP is estimated to affect 30% of women aged 50- 89 years, and the lifetime risk of requiring surgery is 11%. Open abdominal sacrocolpopexy is the established gold standard procedure and is indicated when there is prolapse of the anterior and/or apical vaginal wall compartments. Laparoscopic sacrocolpopexy (LSCP) has not been widely adopted as it demands skill and motivation and it is associated with a long learning curve. So the hypothesis is that robot-assisted laparoscopic approach for sacrocolpopexy (RALSCP) could be an alternative to a pure laparoscopic technique. In the study design 62 patients will be randomly enrolled (31 in the laparoscopic arm and 31 in the robotic assisted one). The primary outcome will be the anatomic one, secondary outcomes will be functional in terms of storage or voiding dysfunctions, sexual dysfunctions, bowel dysfunctions, QoL, post operative complications. For continuous variables will be used the Mann-Withney test, for categorical data will be used McNemar test and X2 test.

Official Title
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Perspective Randomized Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: sacrocolpopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic POP >2 stage according to POP Q system Exclusion Criteria: Obesity Heart failure (NYHA III-IV) High stage COPD (Chronic Obstructive Pulmonary Disease) Patients who underwent more than 2 previous abdominal surgical procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic sacrocolpopexy<br>The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic | Procedure: sacrocolpopexy<br>* Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture<br>|
| Active Comparator: Robotic assisted Sacrocolpopexy<br>The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted | Procedure: sacrocolpopexy<br>* Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical outcome | POP <2 according to POP-Q system | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative ando post operative complications | Clavien-Dindo classification of surgery complications | during surgery and within 90 days after surgery | 
| post operative pain | VAS score (Visual Analog Pain Scale) | within 7 days after surgery | 
| voiding and storage symptoms | fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms | 2, 6, 12 months after surgery | 
| sexual dysfunctions | fill in Female Sexual Function Index questionnaire (FSFI) | 2, 6, 12 months after surgery | 
| patient satisfaction | fill in Patient Global Impression of Improvement (PGI-I) | 12 months after surgery | 
| Quality of life | fill in Incontinence Impact Questionnaire-Short form (IIQ-7) | 2, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Sacrocolpopexy, Robotic Assisted Sacrocolpopexy, Pelvic Organ Prolapse