Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries

NCT ID: NCT05930795

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-09-10

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.

Detailed Description

Pelvic organ prolapse (POP) can be defined as the protrusion of the pelvic organs out of the vagina. Many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. POP causes various undesirable effects in terms of sexual life and body aesthetics in women. With the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common.

Patients who had laparoscopic pectopexy operation due to minimum POPQ stage 2 according to the International Classification of Pelvic Organ Prolapse Quantification (POP Q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. In the first group, patients who had laparoscopic pectopexy operation were planned to be included. In the second group, it was planned to include patients who had ls lateral suspension operation.

Demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op Pelvic prolapse (with POP-Q classification), PopQ values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. Furthermore, the patients will be called back and Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PİS-Q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Patients with pelvic organ prolapse undergone pectopexy surgery

Group Type: ACTIVE_COMPARATOR

pectopexy

Intervention Type: PROCEDURE

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

Patients with pelvic organ prolapse undergone lateral suspension surgery

Group Type: ACTIVE_COMPARATOR

lateral suspension

Intervention Type: 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

Interventions

pectopexy

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

Intervention Type: PROCEDURE

lateral suspension

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

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Serkan Kumbasar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpaşaTREHv

Identifier Type: -

Identifier Source: org_study_id