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

Ain Shams Maternity Hospital

Status: Completed

Conditions: Laparoscopy; Hysterectomy

Treatments: Procedure: Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03698604

TLH-TAH-EN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

Total Laparoscopic Hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Hysterectomy

Total Abdominal hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Hysterectomy