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Haemorrhoidectomy by Ligasure and Conventional Surgery

This study is not yet open for participant recruitment.
Verified August 2017 by Abdulrahman Refaay Ahmed, Assiut University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03265990
First Posted: August 29, 2017
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abdulrahman Refaay Ahmed, Assiut University
  Purpose
Comparison between Haemorrhoidectomy by Ligasure and conventional surgery

Condition Intervention
Ligature; Hemorrhage Procedure: ligasure haemroidectomy Procedure: Conventional haemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery

Resource links provided by NLM:


Further study details as provided by Abdulrahman Refaay Ahmed, Assiut University:

Primary Outcome Measures:
  • Post operative pain [ Time Frame: 1 month ]
    pain will be evaluated with visual analogue scale


Secondary Outcome Measures:
  • Intra operative blood loss [ Time Frame: 1 day ]
    Amount of blood loss by cc during surgery

  • Wound healing [ Time Frame: 2 months ]
    the healing of mucosa and skin


Estimated Enrollment: 40
Anticipated Study Start Date: September 1, 2017
Estimated Study Completion Date: February 1, 2019
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Conventional haemrrhoidectomy,Ferguson technique
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.

Experimental: Group B
Ligasure haemorrhoidectomy
Procedure: 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265990


Contacts
Contact: Abdel Rhman Refaie Kamel 01097722233 Refaay120@gmail.com

Sponsors and Collaborators
Assiut University
  More Information

Responsible Party: Abdulrahman Refaay Ahmed, araahmed, Assiut University
ClinicalTrials.gov Identifier: NCT03265990     History of Changes
Other Study ID Numbers: ligaHaemorrhoidectomy
First Submitted: August 19, 2017
First Posted: August 29, 2017
Last Update Posted: August 29, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes