Pelvic Organ Prolapse
Conditions
Keywords
Laparoscopic Sacrocolpopexy, Robotic Assisted Sacrocolpopexy, Pelvic Organ Prolapse
Brief summary
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
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.
Interventions
PROCEDUREsacrocolpopexy
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
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical outcome | 12 months | POP \<2 according to POP-Q system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post operative pain | within 7 days after surgery | VAS score (Visual Analog Pain Scale) |
| voiding and storage symptoms | 2, 6, 12 months after surgery | fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms |
| Intraoperative ando post operative complications | during surgery and within 90 days after surgery | Clavien-Dindo classification of surgery complications |
| patient satisfaction | 12 months after surgery | fill in Patient Global Impression of Improvement (PGI-I) |
| Quality of life | 2, 6, 12 months | fill in Incontinence Impact Questionnaire-Short form (IIQ-7) |
| sexual dysfunctions | 2, 6, 12 months after surgery | fill in Female Sexual Function Index questionnaire (FSFI) |
Countries
Italy
Contacts
Primary ContactElisabetta Costantini, MD
Backup ContactEster Illiano, MD
Outcome results
None listed