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

Primary Purpose

Hysterectomy, Laparoscopy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hysterectomy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hysterectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Laparoscopic Hysterectomy

Total Abdominal hysterectomy

Arm Description

The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.

The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.

Outcomes

Primary Outcome Measures

Operative time
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.

Secondary Outcome Measures

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).
Blood transfusion
The need to blood transfusion to the patient.
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).
Hospital stay
Hospital stay duration in days.
Incidence of operative complications
The need for laparotomy, and bowel or bladder or ureteric injury.
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.

Full Information

First Posted
September 26, 2018
Last Updated
October 4, 2018
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03698604
Brief Title
Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia
Official Title
Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Laparoscopic Hysterectomy
Arm Type
Active Comparator
Arm Description
The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.
Arm Title
Total Abdominal hysterectomy
Arm Type
Active Comparator
Arm Description
The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.
Intervention Type
Procedure
Intervention Name(s)
Hysterectomy
Intervention Description
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.
Time Frame
From skin incision till closure of the vault "up to 4 hours".
Secondary Outcome Measure Information:
Title
Blood loss
Description
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).
Time Frame
From skin incision start until skin suturing is finished "up to 4 hours".
Title
Blood transfusion
Description
The need to blood transfusion to the patient.
Time Frame
From admission to the hospital until the home discharge "up to 1 week".
Title
Postoperative pain
Description
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).
Time Frame
8 hours after the end of operation.
Title
Hospital stay
Description
Hospital stay duration in days.
Time Frame
From admission to the hospital until the home discharge "up to 1 week".
Title
Incidence of operative complications
Description
The need for laparotomy, and bowel or bladder or ureteric injury.
Time Frame
During operation.
Title
Incidence of postoperative complications
Description
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.
Time Frame
Up to 1 week postoperative.

10. Eligibility

Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid E Mohammed, MD
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mortada E Ahmed, MD
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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