A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hysteromyoma
- Sponsor
- Mansoura University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Operative Time (min)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Tarek Shokeir
Prof. Obstetrics & Gynecology
Mansoura University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
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
- Early postoperative complications(Within 30 days after operation)