Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy

• ClinicalTrials.gov Identifier: NCT03228654
• Recruitment Status: Terminated
• First Posted: July 25, 2017
• Last Update Posted: January 20, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ahmed Abass, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vaginal Hysterectomy	Procedure: Unipolar Electrocautery sealing of vessels; Procedure: Purohit technique for vaginal hysterectomy	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)
• Actual Study Start Date: August 1, 2016
• Actual Primary Completion Date: February 1, 2019
• Actual Study Completion Date: February 1, 2019

Arms and Interventions

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 Name: 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 Name: Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

Outcome Measures

Primary Outcome Measures :

1. Intraoperative blood loss [ Time Frame: 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 :

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

Other Outcome Measures:

1. postoperative complication [ Time Frame: 1 week after procedure ]
   bleeding
2. postoperative complication [ Time Frame: 1 week after procedure ]
   burns
3. postoperative complication [ Time Frame: 1 week after procedure ]
   haemtoma
4. postoperative complication [ Time Frame: 1 week after procedure ]
   urinary tract infections
5. postoperative complication [ Time Frame: 1 week after procedure ]
   surgical site infection
6. postoperative complication [ Time Frame: 1 week after procedure ]
   blood transfusion

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Egypt

Ahmed Abass

Cairo, Egypt, 11311

Sponsors and Collaborators

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

More Information

• Responsible Party: Ahmed Abass, Lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03228654
• Other Study ID Numbers: Obs3514
• First Posted: July 25, 2017
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

• 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