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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698604
Other study ID # TLH-TAH-EN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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