Haemorrhoidectomy by Ligasure and Conventional Surgery

NCT ID: NCT03265990

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-02-01

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.

Conditions

Ligature; Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Conventional haemrrhoidectomy,Ferguson technique

Group Type: EXPERIMENTAL

Conventional haemorrhoidectomy

Intervention Type: PROCEDURE

According to the Ferguson technique

• Manual anal sphincter stretching up to 4 fingers
• Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.
• skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.

After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.

Group B

Ligasure haemorrhoidectomy

Group Type: EXPERIMENTAL

ligasure haemroidectomy

Intervention Type: PROCEDURE

In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.

Interventions

ligasure haemroidectomy

In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.

Intervention Type: PROCEDURE

Conventional haemorrhoidectomy

According to the Ferguson technique

• Manual anal sphincter stretching up to 4 fingers
• Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.
• skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.

After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdulrahman Refaay Ahmed

araahmed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdel Rhman Refaie Kamel

Role: CONTACT

Refaay120@gmail.com

01097722233

Other Identifiers

ligaHaemorrhoidectomy

Identifier Type: -

Identifier Source: org_study_id