Haemorrhoidectomy by Ligasure and Conventional Surgery

Study Overview
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Brief Summary
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Comparison between Haemorrhoidectomy by Ligasure and conventional surgery

Detailed Description
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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.

Official Title
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Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery

Conditions
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Ligature; Hemorrhage

Intervention / Treatment
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* Procedure: ligasure haemroidectomy
* Procedure: Conventional haemorrhoidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Conventional haemrrhoidectomy,Ferguson technique | Procedure: Conventional haemorrhoidectomy<br>* 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.<br>|
| Experimental: Group B<br>Ligasure haemorrhoidectomy | Procedure: ligasure haemroidectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | pain will be evaluated with visual analogue scale | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra operative blood loss | Amount of blood loss by cc during surgery | 1 day | 
| Wound healing | the healing of mucosa and skin | 2 months |