Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries

Evaluation of the Comparison of Anatomical and Functional Results of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries for the Treatment of Pelvic Organ Prolapse

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Pelvic Organ Prolapse; Pectopexy; Lateral Suspension; Pop-q; Pisq-12
• Intervention / Treatment: Procedure: pectopexy; Procedure: lateral suspension

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serkan Kumbasar, MD; Phone Number: +905067873216; Email: doktor1977@hotmail.com
• Study Contact Backup: Name: Fatma Ketenci Gencer, MD; Phone Number: 05416116469; Email: fathma_k@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Gaziosmanpasa Training and Research Hospital
    • Contact: Fatma Ketenci Gencer, MD; Phone Number: +905416116469; Email: fathma_k@hotmail.com
    • Contact: Serkan Kumbasar, MD; Phone Number: +905067873216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with pelvic organ prolapse undergone pectopexy surgery	Procedure: pectopexy; pectopexy: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament; Other Names: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament
Active Comparator: Patients with pelvic organ prolapse undergone lateral suspension surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): August 10, 2023
• Study Completion (Estimated): September 10, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: GaziosmanpaşaTREHv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No