Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy

NCT ID: NCT03228654

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2019-02-01

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.

Conditions

Vaginal Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Unipolar electrocautery

vaginal hysterectomy using Unipolar electrocautery

Group Type: EXPERIMENTAL

Unipolar Electrocautery sealing of vessels

Intervention Type: PROCEDURE

1. Vaginal walls are incised by monoplar current (40 W)

2. 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.

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 to approach the lateral attachements.

Purohit's technique

Vaginal hysterectomy using Purohit's technique

Group Type: ACTIVE_COMPARATOR

Purohit technique for vaginal hysterectomy

Intervention Type: PROCEDURE

using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

Interventions

Unipolar Electrocautery sealing of vessels

1. Vaginal walls are incised by monoplar current (40 W)

2. 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.

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 to approach the lateral attachements.

Intervention Type: PROCEDURE

Purohit technique for vaginal hysterectomy

using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

Intervention Type: PROCEDURE

Other Intervention Names

Monopolar Electrocautery sealing of vessels; Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abass

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Tharwat, Ass. prof

Role: STUDY_DIRECTOR

Ain Shams University

Amr H Yehia, Ass.prof

Role: STUDY_CHAIR

Ain Shams University

Alaa MA Karim El-din, ass. lect

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ahmed Abass

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Obs3514

Identifier Type: -

Identifier Source: org_study_id