Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy

Phase 4

Terminated

• Conditions: Vaginal Hysterectomy
• Interventions: Procedure: Unipolar Electrocautery sealing of vessels; Procedure: Purohit technique for vaginal hysterectomy

• Registration Number: NCT03228654
• Lead Sponsor: Ain Shams University

Brief Summary

Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof the development of alternative treatments, the incidence of hysterectomy doesn't appear to be declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be performed in preference to abdominal hysterectomy.

Detailed Description

A pilot prospective randomized clinical trial will be conducted at Ain shams University Maternity Hospital during the period from August 2016 to August 2018.

A sample size of 50 cases will be recruited from women presenting to the outpatient gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years. Uterus size should be \< 12 weeks with absence of significant scarring in the pelvis from previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be excluded. After approval of the ethical committee , a detailed explanation of the procedure will e informed to the participant \& her approval to be involved in the study, an informed written consent will be taken. After that, included patients will be randomized into 2 groups each one include 25 patients. First group includes women who will undergo vaginal hysterectomy using monopolar electrocautery. Second group includes women who will undergo vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1. Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o elevate, hook, stretch, spread and retract all the lateral attacements of uterus \& vessels from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided between the prongs of forceps. 3. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.

Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm lateral to uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• uterine size <12 weeks.
• presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal beeding not responding to medical treatment or complex endometrial hyperplasia without atypia.
• Absence of significant scarring in the pelvis from previous surgeries.

Exclusion Criteria

• Suspected or known gynecological malignancy.
• uterine size >12 weeks.
• Endometriosis
• Presence of adnexal mass.
• cervix flushed with the vagina.
• presence of significant scarring in the pelvic area from previous surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unipolar electrocautery	Unipolar Electrocautery sealing of vessels	vaginal hysterectomy using Unipolar electrocautery
Purohit's technique	Purohit technique for vaginal hysterectomy	Vaginal hysterectomy using Purohit's technique

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	5 minutes after end if the procedure	assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	1 week after procedure	number of days after the procedure the patient stay at the hospital
operative time	5 minutes after end of the procedure	will be accounted from time of vaginal mucous membrane incision till closure of the vault.
postoperative pain	24 hours postoperative	pain scale will be used to assess pain

Trial Locations

Locations (1)

Ahmed Abass; 🇪🇬 Cairo, Egypt