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Completed

NCT Number: NCT07094815

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anatomical Success Based on POP-Q System

    Time frame: 12 months after surgery

    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

Sponsors and collaborators

Lead sponsor

Havva Betül Bacak

Other Gov

Registry information

Official study title

Comparative Outcomes of Uterus-Preserving and Hysterectomy Approaches in Laparoscopic Lateral Suspension

Acronym: LLS-HYS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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