Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

Not Applicable

• Conditions: Minimally Invasive Hysterectomy in Large Uteri
• Interventions: Procedure: Vaginal hysterectomy; Procedure: Laparoscopic assisted vaginal hysterectomy

• Registration Number: NCT02826304
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2016-05
• Study First Submitted: 2016-06-28
• Status Verified: 2016-07
• Study Completion: 2016-07
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VH	Vaginal hysterectomy	Vaginal Hysterectomy for uteri larger than 280gm
LAVH	Laparoscopic assisted vaginal hysterectomy	Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm

Primary Outcome Measures

Name	Time	Method
Operative time of the procedure	Range from 90 minutes to 210 minutes	In case of vaginal hysterectomy, the operative time will be measured from the vaginal incision to closure of the vaginal vault. in cases of Laparoscopic assisted vaginal hysterectomy, the time will be measured from the introduction of the laparoscopic camera port till stitching the laparoscopic incisions after ensuring adequate hemostasis. the time of any concomitant procedures was excluded

Secondary Outcome Measures

Name	Time	Method
intraoperative complications	the operative time of the procedure which range from 90 minutes to 210 minutes	1. - need for blood transfusion; 2. - need for laparotomy due to either surgical difficulty or any complication; 3. - Bowel or urinary tract injuries
Postoperative Pain	the first 24hrs after the procedure	Postoperative pain will be assessed using the visual analogue scale after the procedure by 6hrs, 12hrs and 24hrs.
Postoperative complications	1 month after the procedure	1. - Need for blood transfusion; 2. - Vaginal vault or pelvic hematoma; 3. - surgical site infection; 4. - urinary tract infection; 5. - postoperative bowel or urinary tract complications
postoperative hospital stay	range from 24 hours to 168 hours	the hospital stay will be measured in hours
Estimated intraoperative blood loss	the operative time of the procedure which range from 90 minutes to 210 minutes	intraoperative blood loss will be estimated via: 1. - amount of blood in suction bottle.; 2. - Estimation based on number of soaked gauzes by weighing the gauzes used in the procedure before and after surgery ( each 1mg corresponds to 1ml of blood); 3. - Drop in postoperative hemoglobin and hematocrit when compared with preoperative values.
Hospital costs	within the period of hospital admission which range from 2 to 8 days	the costs of the following will be calculated: 1. - Admission cost which include ward fee, pre and postoperative management costs and extra charges for post surgical complication.; 2. - anesthesia cost which includes expenses of anesthetics during the procedure. C)- operation cost which include operative material fee.

Trial Locations

Locations (1)

Maternity hospital, Ain Shams University; 🇪🇬 Cairo, Egypt