Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Minimally Invasive Hysterectomy in Large Uteri

Treatments: Procedure: Laparoscopic assisted vaginal hysterectomy; Procedure: Vaginal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02826304

1

Details and patient eligibility

About

The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes

Full description

Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.

Study duration : the study will be carried out during the period from August 2014 to August 2016.

Sample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.

intervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded

Enrollment: 50 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 40 and 70 years.
2. Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.
3. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.

Exclusion criteria

1. Patients medically unfit for laparoscopy as severely compromised cardiac patients.
2. Obese patients (BMI>30).
3. Presence of endometriosis.
4. Previous myomectomy
5. Presence of adnexal mass
6. Known or suspected gynecological malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

VH

Active Comparator group

Description:

Vaginal Hysterectomy for uteri larger than 280gm

Treatment:

Procedure: Vaginal hysterectomy

LAVH

Active Comparator group

Description:

Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm

Treatment:

Procedure: Laparoscopic assisted vaginal hysterectomy