Haemorrhoidectomy by Ligasure and Conventional Surgery
Primary Purpose
Ligature; Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ligasure haemroidectomy
Conventional haemorrhoidectomy
Sponsored by

About this trial
This is an interventional treatment trial for Ligature; Hemorrhage
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Conventional haemrrhoidectomy,Ferguson technique
Ligasure haemorrhoidectomy
Outcomes
Primary Outcome Measures
Post operative pain
pain will be evaluated with visual analogue scale
Secondary Outcome Measures
Intra operative blood loss
Amount of blood loss by cc during surgery
Wound healing
the healing of mucosa and skin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03265990
Brief Title
Haemorrhoidectomy by Ligasure and Conventional Surgery
Official Title
Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligature; Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Conventional haemrrhoidectomy,Ferguson technique
Arm Title
Group B
Arm Type
Experimental
Arm Description
Ligasure haemorrhoidectomy
Intervention Type
Procedure
Intervention Name(s)
ligasure haemroidectomy
Intervention Description
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
Intervention Name(s)
Conventional haemorrhoidectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operative pain
Description
pain will be evaluated with visual analogue scale
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Intra operative blood loss
Description
Amount of blood loss by cc during surgery
Time Frame
1 day
Title
Wound healing
Description
the healing of mucosa and skin
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdel Rhman Refaie Kamel
Phone
01097722233
Email
Refaay120@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Haemorrhoidectomy by Ligasure and Conventional Surgery
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