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

NCT ID: NCT03848468

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2014-09-30

Brief Summary

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

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CH(conventional Hemorrhoidectomy)

conventional hemorrhoidectomy

Group Type: ACTIVE_COMPARATOR

Hemorrhoidectomy

Intervention Type: PROCEDURE

excision of 3rd and 4th degree hemorrhoids

LH (Ligasure Hemorrhoidectomy)

Ligasure hemorrhoidectomy

Group Type: EXPERIMENTAL

Hemorrhoidectomy

Intervention Type: PROCEDURE

excision of 3rd and 4th degree hemorrhoids

Interventions

Hemorrhoidectomy

excision of 3rd and 4th degree hemorrhoids

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Services Hospital, Lahore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Safia Zahir Ahmed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

services Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

ServicesH

Identifier Type: -

Identifier Source: org_study_id