Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

Study Overview
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Brief Summary
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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
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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

Official Title
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Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)

Conditions
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Minimally Invasive Hysterectomy in Large Uteri

Intervention / Treatment
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* Procedure: Vaginal hysterectomy
* Procedure: Laparoscopic assisted vaginal hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 and 70 years. 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. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis. Exclusion Criteria: Patients medically unfit for laparoscopy as severely compromised cardiac patients. Obese patients (BMI>30). Presence of endometriosis. Previous myomectomy Presence of adnexal mass Known or suspected gynecological malignancy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VH<br>Vaginal Hysterectomy for uteri larger than 280gm | Procedure: Vaginal hysterectomy<br>* All the cases were performed by the same surgical team Incision is made at the anterior cervical lip below the bladder reflection Anterior peritoneal entry . Douglas pouch entry. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated . Uterine artery clamping division and ligation After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament). Hemostasis The vaginal vault is closed after insertion of intraperitoneal drain and<br>|
| Active Comparator: LAVH<br>Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm | Procedure: Laparoscopic assisted vaginal hysterectomy<br>* Uterine manipulator was inserted through the cervix to mobilize the uterus Veress needle was inserted through the base of the umbilicus creation of pneumoperitoneum Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars The round and the utero-ovarian ligament are coagulated and divided. Dissection through the vesico-uterine space to displace bladder away from the cervix. Uterine artery was coagulated and divided laparoscopically anterior colpotomy over the cup of the uterine elevator. Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time of the procedure | 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 | Range from 90 minutes to 210 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Hysterectomy, Laparoscopic assisted vaginal hysterectomy, Large uteri