Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia

Study Overview
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Brief Summary
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The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

Detailed Description
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Research Questions: Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia? Research Hypothesis: In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.

Official Title
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Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial

Conditions
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Hysterectomy, Laparoscopy

Intervention / Treatment
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* Procedure: Hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of perimenopausal bleeding Early stage endometrial carcinoma. Endometrial hyperplasia with/without atypia. Exclusion Criteria: Obese patients i.e., BMI< 29 k.g/m2. Patients unfit for laparoscopy as patients with cardio-pulmonary compromise. Presence of adnexal mass. End stage endometrial carcinoma stage 3 & 4.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 Laparoscopic Hysterectomy<br>The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy. | Procedure: Hysterectomy<br>* Total Laparoscopic Hysterectomy Total Abdominal hysterectomy<br>|
| Active Comparator: Total Abdominal hysterectomy<br>The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy. | Procedure: Hysterectomy<br>* Total Laparoscopic Hysterectomy Total Abdominal hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures. | From skin incision till closure of the vault up to 4 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Intra operative blood loss will be estimated via: Amount of blood in the suction bottle. Estimation will be based on number of soaked gauzes and towels (soaked gauze = 20 ml blood; soaked towel = 150 ml; semi soaked towel = 75 ml). | From skin incision start until skin suturing is finished up to 4 hours. | 
| Blood transfusion | The need to blood transfusion to the patient. | From admission to the hospital until the home discharge up to 1 week. | 
| Postoperative pain | Assessment of pain intensity using Visual Analog Scale (VAS) which is one-dimensional measure of pain intensity. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100). | 8 hours after the end of operation. | 
| Hospital stay | Hospital stay duration in days. | From admission to the hospital until the home discharge up to 1 week. | 
| Incidence of operative complications | The need for laparotomy, and bowel or bladder or ureteric injury. | During operation. | 
| Incidence of postoperative complications | Morbidities e.g.: Vaginal vault hematoma or pelvic hematoma or abscess. Surgical site infection. Urinary tract infection. Need for post-operative blood transfusion. Postoperative bowel or urinary tract complications. | Up to 1 week postoperative. |