Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

Not Applicable

Completed

• Conditions: Hysteromyoma
• Interventions: Procedure: Surgical procedure, Hysterectomy

• Registration Number: NCT03251677
• Lead Sponsor: Mansoura University

Brief 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.

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 Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Study Start: 2017-09-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-03-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total laparo hysterectomy	Surgical procedure, Hysterectomy	Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)
Mini-lap hysterectomy	Surgical procedure, Hysterectomy	Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)

Primary Outcome Measures

Name	Time	Method
Operative Time (min)	Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)	Time in minutes taken for total hysterectomy
Estimated blood loss (mL)	Through surgical intervention completion	Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values

Secondary Outcome Measures

Name	Time	Method
Early postoperative complications	Within 30 days after operation	Related complications

Trial Locations

Locations (1)

Tarek Shokeir; 🇪🇬 Mansoura, Egypt