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

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Laparoscopy
• Intervention / Treatment: Procedure: Hysterectomy

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Laparoscopic Hysterectomy; The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.	Procedure: Hysterectomy; Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
Active Comparator: Total Abdominal hysterectomy; The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.	Procedure: Hysterectomy; Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Walid E Mohammed, MD, Ain Shams Maternity Hospital; Study Director: Mortada E Ahmed, MD, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: TLH-TAH-EN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No