Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

September 27, 2019 updated by: Tarek Shokeir, Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Tarek Shokeir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Total laparo hysterectomy
Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)
Procedure: Surgical procedure, Hysterectomy
Surgical removal of the uterus
ACTIVE_COMPARATOR: Mini-lap hysterectomy
Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)
Procedure: Surgical procedure, Hysterectomy
Surgical removal of the uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
Estimated blood loss (mL)
Time Frame: Through surgical intervention completion
Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values
Through surgical intervention completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative complications
Time Frame: Within 30 days after operation
Related complications
Within 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Tarek Shokeir, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (ACTUAL)

August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MD/16.12.51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing up to scientific publication of a manuscript

IPD Sharing Time Frame

Up to scientific publication of a manuscript

IPD Sharing Access Criteria

Personal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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