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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251677
• Other study ID #: MD/16.12.51
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hysteromyoma

Intervention

Procedure:
• Surgical procedure, Hysterectomy
Surgical removal of the uterus

Locations

Country	Name	City	State
Egypt	Tarek Shokeir	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Time (min)	Time in minutes taken for total hysterectomy	Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
Primary	Estimated blood loss (mL)	Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values	Through surgical intervention completion
Secondary	Early postoperative complications	Related complications	Within 30 days after operation