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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ligature; Hemorrhage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 19, 2017
    Last Updated
    August 28, 2017
    Sponsor
    Assiut University
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    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

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    Haemorrhoidectomy by Ligasure and Conventional Surgery

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