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Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.

S

Services Hospital, Lahore

Status

Completed

Conditions

Hemorrhoids Third Degree
Wound Healing
Hemorrhoidectomy
Hemorrhoids Fourth Degree
Pain, Postoperative
Return to Work
Operative Time

Treatments

Procedure: Hemorrhoidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03848468
ServicesH

Details and patient eligibility

About

A comparison study was performed between Ligasure and Milligan morgan hemorrhoidectomy to find out the outcome between these two techniques in 3rd and 4th degree hemorrhoids.This advance vessel sealing device is used to seal the pedicle of the vessel and does not burn the surrounding tissues , so the outcome was monitored in terms of operative time, post operative pain pain, duration of wound healing in 3 weeks and return to normal activities

Full description

INTRODUCTION:

Milligan Morgan hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in ligasure hemorrhoidectomy have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time, wound healing and return to normal activities.

OBJECTIVES:

To compare the outcome of ligasure hemorrhoidectomy with conventional hemorrhoidectomy in III and IV degree hemorrhoids.

STUDY DESIGN:

Randomized controlled trial

STUDY SETTING:

The study was conducted in surgical unit 1, Services hospital, Lahore.

DURATION OF STUDY:

Study was completed in six months after the approval of synopsis i.e. from 1st April 2014 to 30th September 2014.

DATA COLLECTION PROCEDURE:

After approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria has been recruited from outdoor and emergency department. A detailed history had been taken including demographic data (age, address) and all patients had been clinically examined .Patients was divided in two groups randomly using random number tables. Group A: Conventional hemorrhoidectomy. Group B: Ligasure hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures have been performed by a single surgical operating team to control bias. Preoperatively operative time was noted. Post operatively pain had been assessed after 6 hours, 24 hours, and 48 hours, wound has been assessed in 2nd and 3rd postoperative week to assess epithelization and return to normal activities in days. All data had been collected and recorded on the Proforma

Enrollment

100 patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients with III and IV degree hemorrhoids assessed on proctoscopy had been included in this study.

Exclusion criteria

  • Patients with permanently prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
  • Any other anorectal pathology on history and per rectal examination
  • Previous anal surgery assessed by history and per rectal examination
  • Inability to give informed consent
  • ASA(American Society of Anesthesiologists) grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic and renal profile and evidence of ischemic heart disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

CH(conventional Hemorrhoidectomy)
Active Comparator group
Description:
conventional hemorrhoidectomy
Treatment:
Procedure: Hemorrhoidectomy
LH (Ligasure Hemorrhoidectomy)
Experimental group
Description:
Ligasure hemorrhoidectomy
Treatment:
Procedure: Hemorrhoidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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