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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698604
• Other study ID #: TLH-TAH-EN
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2018
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Hysterectomy
• Laparoscopy

Intervention

Procedure:
• Hysterectomy
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".
Secondary	Blood transfusion	The need to blood transfusion to the patient.	From admission to the hospital until the home discharge "up to 1 week".
Secondary	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.
Secondary	Hospital stay	Hospital stay duration in days.	From admission to the hospital until the home discharge "up to 1 week".
Secondary	Incidence of operative complications	The need for laparotomy, and bowel or bladder or ureteric injury.	During operation.
Secondary	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.