Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hysteromyoma

Intervention / Treatment
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* Procedure: Surgical procedure, Hysterectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total laparo hysterectomy<br>Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy) | Procedure: Surgical procedure, Hysterectomy<br>* Surgical removal of the uterus<br>|
| Active Comparator: Mini-lap hysterectomy<br>Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy) | Procedure: Surgical procedure, Hysterectomy<br>* Surgical removal of the uterus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Estimated blood loss (mL) | 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 | Related complications | Within 30 days after operation |