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Completed

NCT Number: NCT03251677

Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

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Key information

Conditions

Hysteromyoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tarek Shokeir

Al Mansurah, 35516, Egypt

About this study

A prospective randomized open-label study was conducted. Women >18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.

Inclusion criteria

were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks, suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.

Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Mobile uterus.
  • Uterine size up to 12 weeks gestation.
  • Benign lesions.

Exclusion criteria

  • Enlarged uterus > 12 weeks gestation.
  • Suspected malignancy.
  • Large adnexal masses.

Treatment and study plan

Surgical procedure, Hysterectomy

Procedure

Surgical removal of the uterus

Primary outcomes

  1. Operative Time (min)

    Time frame: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)

    Time in minutes taken for total hysterectomy

  2. Estimated blood loss (mL)

    Time frame: Through surgical intervention completion

    Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values

Secondary outcomes

  1. Early postoperative complications

    Time frame: Within 30 days after operation

    Related complications

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2017
Registry last updated
Sep 30, 2019

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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