Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

Hysteromyoma Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hysteromyoma

• NCT number: NCT03251677
• Study type: Interventional
• Source: Mansoura University
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Completion date: March 1, 2019