Clinical trial NCT03228654: Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy
Official title: Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vaginal Hysterectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 5 minutes after end if the procedure
Secondary outcomes:
measure: operative time
timeFrame: 5 minutes after end of the procedure
measure: postoperative pain
timeFrame: 6 hours postoperative
measure: postoperative pain
timeFrame: 12 hours postoperative
measure: postoperative pain
timeFrame: 24 hours postoperative
measure: Hospital stay
timeFrame: 1 week after procedure
Other outcomes:
measure: postoperative complication
timeFrame: 1 week after procedure
measure: postoperative complication
timeFrame: 1 week after procedure
measure: postoperative complication
timeFrame: 1 week after procedure
measure: postoperative complication
timeFrame: 1 week after procedure
measure: postoperative complication
timeFrame: 1 week after procedure
measure: postoperative complication
timeFrame: 1 week after procedure
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abass
Study officials:
affiliation: Ain Shams University
name: Ahmed A Tharwat, Ass. prof
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Amr H Yehia, Ass.prof
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Alaa MA Karim El-din, ass. lect
role: PRINCIPAL_INVESTIGATOR
References: