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OpenTrials
Completed

NCT Number: NCT04904822

Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

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Key information

Conditions

Hysterectomy Laparoscopy Large Uteri Uterine Bisection

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

About this study

Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • large uterus ≥ 12weeks,
  • benign pathology,
  • mobile uterus
  • BMI less than 30kg/m2

Exclusion criteria

  • unfit for laparoscopy,
  • Extensive pelvic adhesions,
  • Extensive endometriosis
  • malignancy
  • virgin cases

Treatment and study plan

Vaginal bisection

Procedure

Uterine bisection vaginally by scalpel 24

Abdominal bisection

Procedure

Uterine bisection by endokinfe

Primary outcomes

  1. Retrieval time of uterus

    Time frame: 6 months

    Time from end of colpotomy to extraction of uterus

  2. Blood loss

    Time frame: 6 months

    Amount of blood in suction

Secondary outcomes

  1. Injury of other organs

    Time frame: 6 months

    Number of cases with intraoperative injuries

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Abdominal Versus Vaginal Uterine Bisection for Retrieval of Large Uteri During Laparoscopic Hysterectomy: A Randomized Controlled Study

Acronym: TLH-Bisection

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 27, 2021
Registry last updated
Mar 13, 2024

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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