Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy

Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)

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.

Study Overview

• Status: Terminated
• Conditions: Vaginal Hysterectomy
• Intervention / Treatment: Procedure: Unipolar Electrocautery sealing of vessels; Procedure: Purohit technique for vaginal 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Ahmed Abass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unipolar electrocautery; vaginal hysterectomy using Unipolar electrocautery	Procedure: Unipolar Electrocautery sealing of vessels; Vaginal walls are incised by monoplar current (40 W); A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm.; uterine vessels are individually secured.; Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements.; Other Names: Monopolar Electrocautery sealing of vessels
Active Comparator: Purohit's technique; Vaginal hysterectomy using Purohit's technique	Procedure: Purohit technique for vaginal hysterectomy; using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy; Other Names: Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	will be accounted from time of vaginal mucous membrane incision till closure of the vault.	5 minutes after end of the procedure
postoperative pain	pain scale will be used to assess pain	6 hours postoperative
postoperative pain	pain scale will be used to assess pain	12 hours postoperative
postoperative pain	pain scale will be used to assess pain	24 hours postoperative
Hospital stay	number of days after the procedure the patient stay at the hospital	1 week after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complication	bleeding	1 week after procedure
postoperative complication	burns	1 week after procedure
postoperative complication	haemtoma	1 week after procedure
postoperative complication	urinary tract infections	1 week after procedure
postoperative complication	surgical site infection	1 week after procedure
postoperative complication	blood transfusion	1 week after procedure

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed A Tharwat, Ass. prof, Ain Shams University; Study Chair: Amr H Yehia, Ass.prof, Ain Shams University; Principal Investigator: Alaa MA Karim El-din, ass. lect, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Obs3514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No