Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries

NCT05930795 | Completed

• 1 other identifier: GaziosmanpaşaTREHv
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

Conditions

Patients With Pelvic Organ Prolapse; Pectopexy; Lateral Suspension; Pop-q; Pisq-12

Outcome Measures

Primary Outcomes (2)

• Comparison of pre and post operative assessment of POP-Q measurements

  Comparison of POP-Q values of patients undergone pectopexy and lateral suspension pre and postoperatively.

  1 year

• Comparison of Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire

  Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire will be compared before and after surgery. PISQ- 12 is a Likert type of survey with five options (scoring from 0 to 4) in each question and the patient is asked a total of 12 questions. The total score is calculated by summing points given to each question. A higher score means better sexual function and the highest total score is 48.

  1 year

Study Arms (2)

Patients with pelvic organ prolapse undergone pectopexy surgery

ACTIVE COMPARATOR

Procedure: pectopexy

Patients with pelvic organ prolapse undergone lateral suspension surgery

ACTIVE COMPARATOR

Procedure: lateral suspension

Interventions

pectopexy PROCEDURE

pectopexy: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament

Also known as: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament

Patients with pelvic organ prolapse undergone pectopexy surgery

lateral suspension PROCEDURE

lateral suspension: surgery performed by suspending prolapsed uterus or vault to the lateral walls of the abdomen corresponding to the 3 cm anterior superior to the iliac crest

Patients with pelvic organ prolapse undergone lateral suspension surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,
• Being a Citizen of the Republic of Turkey over the age of 18
• Patients operated by the same experienced surgeons

You may not qualify if:

• To have received chemotherapy and/or radiotherapy for any reason before
• Having previously operated for prolapse
• Cases with Contraindications for Laparoscopy
• Cases with severe cardiovascular or respiratory disease

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 5, 2023
• Study Start: August 10, 2022
• Primary Completion: August 10, 2023
• Study Completion: September 10, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TU (1)