Effectiveness of Laparoscopic Lateral Suspension With or Without Hysterectomy in Pelvic Organ Prolapse

NCT07094815 | Completed

• 1 other identifier: lateralsuspwithuterusornot
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Laparoscopic lateral suspension is a minimally invasive surgical technique used to correct this condition. In some cases, the uterus is preserved, while in others, hysterectomy is performed at the same time. The study retrospectively evaluates patients who underwent laparoscopic lateral suspension, either with or without hysterectomy, at SBÜ Gaziosmanpaşa Training and Research Hospital. Medical records were reviewed to collect information about surgery duration, anatomical success (measured by the POP-Q system), complication rates, blood loss, hospital stay, and recurrence rates. The goal of this study is to determine whether performing a hysterectomy during laparoscopic lateral suspension has a significant effect on surgical outcomes. The findings may help guide surgical decision-making and improve treatment strategies for women with pelvic organ prolapse.

Conditions

Pelvic Organ Prolapse (POP); Uterine Prolapse

Keywords

Laparoscopic Lateral Suspension; Uterus Preservation; Uterine Prolapse; Pelvic Organ Prolapse; Minimally Invasive Surgery; POP-Q System; Surgical Outcomes; Gynecologic Surgery; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Anatomical Success Based on POP-Q System

  Primary Outcome Title: Number of Participants Achieving Anatomical Success Based on POP-Q System Description: Anatomical success is defined as all assessed POP-Q points (Aa, Ba, C, D, Ap, Bp) being at or above -1 cm (no prolapse extending more than 1 cm below the hymen). POP-Q scale values: Negative values indicate the point is above the hymen (better anatomy), positive values indicate prolapse below the hymen (worse anatomy). Typical range: Aa, Ba, Ap, Bp = -3 to +3 cm; C and D vary according to total vaginal length (TVL). Time Frame: 12 months after surgery

  12 months after surgery

Study Arms (2)

LLS with Hysterectomy

Patients who underwent laparoscopic lateral suspension combined with total laparoscopic hysterectomy.

Uterus-Preserving LLS

Patients who underwent laparoscopic lateral suspension with uterine preservation.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients aged 40 to 80 years who underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy for the treatment of pelvic organ prolapse at SBÜ Gaziosmanpaşa Training and Research Hospital between 2021 and 2024. All patients had at least 12 months of postoperative follow-up, and data were collected retrospectively from medical records.

You may qualify if:

• Female patients aged 40 to 80 years
• Diagnosis of pelvic organ prolapse (POP) requiring surgical management
• Underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy
• Minimum of 12 months postoperative follow-up available
• Ability to provide informed consent for use of medical data in this retrospective study

You may not qualify if:

• History of connective tissue disorders
• History of prior pelvic reconstructive surgery
• Active pelvic infection or suspected malignancy at the time of surgery
• Severe systemic disease that could significantly affect surgical outcomes
• Incomplete medical records or missing follow-up data

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Istanbul, Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (1)

• Kumbasar S, Salman S, Sogut O, K Gencer F, Bacak HB, Tezcan AD, Timur GY. Uterine-sparing laparoscopic lateral suspension in the treatment of pelvic organ prolapse. J Obstet Gynaecol Res. 2023 Jan;49(1):341-349. doi: 10.1111/jog.15459. Epub 2022 Oct 5.

  PMID: 36196844 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: May 28, 2025
• Primary Completion: June 28, 2025
• Study Completion: June 28, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)