Skip to main content
Clinical Trials/NCT03265990
NCT03265990UnknownNot Applicable

Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery

Assiut University0 sites40 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Primary Endpoint
Post operative pain

Study Overview

Brief Summary

Comparison between Haemorrhoidectomy by Ligasure and conventional surgery

Detailed Description

Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture which may lead to some postoperative complications mostly pain, bleeding and wound infection which ultimately cause prolonged stay in hospital.

A number of surgeons believe that by avoiding vascular pedicle ligation the chances of secondary bleeding can be decreased .This stimulated the researchers to develop new techniques with a less severe course and faster recovery . Recent advances in instrumental technology including the bipolar electrothermal device, ultrasonic scalpel, and circular stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these instruments, the LigaSure vessel sealing system has been recently introduced as a tool conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast healing . .Thus this operation can be recommended as the ideal technique. Many trials were performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although an overall favorable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for this disposable device: thus it is essential to keep on experimenting to determine whenever an actual advantage exists.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • all patients with ages between 18 to 70 years with symptomatic grade III, or IV hemorrhoid who will be operated on at the Department of general Surgery, Assuit University Hospital

Exclusion Criteria

  • age older than 70 years
  • patients with Grade I and II haemorrhoids
  • patients on anticoagulants
  • patients with liver cirrhosis
  • patients with the hematological disorder
  • patients with the concomitant anal disease
  • patients had previous history of anorectal surgery

Arms & Interventions

Group A

Experimental

Conventional haemrrhoidectomy,Ferguson technique

Intervention: Conventional haemorrhoidectomy (Procedure)

Group B

Experimental

Ligasure haemorrhoidectomy

Intervention: ligasure haemroidectomy (Procedure)

Outcomes

Primary Outcomes

Post operative pain

Time Frame: 1 month

pain will be evaluated with visual analogue scale

Secondary Outcomes

  • Wound healing(2 months)
  • Intra operative blood loss(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdulrahman Refaay Ahmed

araahmed

Assiut University

Similar Trials