NCT03228654

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

July 21, 2017

Last Update Submit

January 16, 2021

Conditions

Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • operative time

    5 minutes after end of the procedure

  • postoperative pain

    6 hours postoperative

  • postoperative pain

    12 hours postoperative

  • postoperative pain

    24 hours postoperative

  • Hospital stay

    1 week after procedure

Other Outcomes (6)

  • postoperative complication

    1 week after procedure

  • postoperative complication

    1 week after procedure

  • postoperative complication

    1 week after procedure

  • +3 more other outcomes

Study Arms (2)

Unipolar electrocautery

EXPERIMENTAL

vaginal hysterectomy using Unipolar electrocautery

Procedure: Unipolar Electrocautery sealing of vessels

Purohit's technique

ACTIVE COMPARATOR

Vaginal hysterectomy using Purohit's technique

Procedure: Purohit technique for vaginal hysterectomy

Interventions

Unipolar Electrocautery sealing of vesselsPROCEDURE

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.

Also known as: Monopolar Electrocautery sealing of vessels
Unipolar electrocautery
Purohit technique for vaginal hysterectomyPROCEDURE

using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy

Also known as: Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
Purohit's technique

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abass

Cairo, 11311, Egypt

Location

MeSH Terms

Interventions

Hysterectomy, Vaginal

Intervention Hierarchy (Ancestors)

HysterectomyGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed A Tharwat, Ass. prof

    Ain Shams University

    STUDY DIRECTOR

  • Amr H Yehia, Ass.prof

    Ain Shams University

    STUDY CHAIR

  • Alaa MA Karim El-din, ass. lect

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 25, 2017

Study Start

August 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

EG(1)