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

Not Applicable

Completed

• Conditions: Laparoscopy; Hysterectomy
• Interventions: Procedure: Hysterectomy

• Registration Number: NCT03698604
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-08-01
• Study First Submitted: 2018-09-26
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-04
• Last Update Submitted: 2018-10-04
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Abdominal hysterectomy	Hysterectomy	The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.
Total Laparoscopic Hysterectomy	Hysterectomy	The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.

Primary Outcome Measures

Name	Time	Method
Operative time	From skin incision till closure of the vault "up to 4 hours".	Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	From admission to the hospital until the home discharge "up to 1 week".	Hospital stay duration in days.
Blood transfusion	From admission to the hospital until the home discharge "up to 1 week".	The need to blood transfusion to the patient.
Postoperative pain	8 hours after the end of operation.	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).
Incidence of operative complications	During operation.	The need for laparotomy, and bowel or bladder or ureteric injury.
Blood loss	From skin incision start until skin suturing is finished "up to 4 hours".	Intra operative blood loss will be estimated via: 1. Amount of blood in the suction bottle.; 2. 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).
Incidence of postoperative complications	Up to 1 week postoperative.	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.

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt