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

NCT ID: NCT07094815

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2025-06-28

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.

Detailed Description

This retrospective cohort study was conducted at SBÜ Gaziosmanpaşa Training and Research Hospital to compare the outcomes of laparoscopic lateral suspension (LLS) with and without concomitant hysterectomy in women with pelvic organ prolapse (POP). POP is a prevalent condition that significantly affects quality of life, and LLS is increasingly performed as a minimally invasive approach that allows either uterine preservation or hysterectomy.

A total of 87 patients treated between 2021 and 2024 were analyzed: 43 underwent LLS with total laparoscopic hysterectomy, and 44 underwent uterus-preserving LLS. Preoperative, intraoperative, and postoperative data were collected from electronic medical records, operative reports, and follow-up documentation, with at least 12 months of follow-up. Outcome measures included POP-Q scores, operative time, blood loss, hospital stay, perioperative complications, recurrence, pelvic pain, and urinary incontinence.

The analysis showed that both groups achieved significant anatomical improvement, with no significant differences in recurrence, pelvic pain, or urinary incontinence. However, hysterectomy was associated with longer operative times, increased blood loss, and longer hospital stays. Vaginal length was better preserved in uterus-preserving procedures. No major intraoperative or postoperative complications occurred.

These findings indicate that adding hysterectomy to LLS increases surgical burden without conferring additional anatomical or functional benefit. Uterus-preserving LLS appears to be a safe and effective option in appropriately selected patients, supporting shared decision-making in pelvic reconstructive surgery.

Conditions

Pelvic Organ Prolapse (POP); Uterine Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

LLS with Hysterectomy

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

No interventions assigned to this group

Uterus-Preserving LLS

Patients who underwent laparoscopic lateral suspension with uterine preservation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Havva Betül Bacak

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Betül Bacak

M.D

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 36196844 (View on PubMed)

Other Identifiers

lateralsuspwithuterusornot

Identifier Type: -

Identifier Source: org_study_id