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

University Of Perugia

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: sacrocolpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT02852512

LVR1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Laparoscopic sacrocolpopexy

Active Comparator group

Description:

The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic

Treatment:

Procedure: sacrocolpopexy

Robotic assisted Sacrocolpopexy

Active Comparator group

Description:

The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted

Treatment:

Procedure: sacrocolpopexy