NCT03265990

Brief Summary

Comparison between Haemorrhoidectomy by Ligasure and conventional surgery

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 19, 2017

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    pain will be evaluated with visual analogue scale

    1 month

Secondary Outcomes (2)

  • Intra operative blood loss

    1 day

  • Wound healing

    2 months

Study Arms (2)

Group A

EXPERIMENTAL

Conventional haemrrhoidectomy,Ferguson technique

Procedure: Conventional haemorrhoidectomy

Group B

EXPERIMENTAL

Ligasure haemorrhoidectomy

Procedure: ligasure haemroidectomy

Interventions

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.

Group B

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 A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Abdel Rhman Refaie Kamel

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
araahmed

Study Record Dates

First Submitted

August 19, 2017

First Posted

August 29, 2017

Study Start

September 1, 2017

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

August 29, 2017

Record last verified: 2017-08