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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Wound Healing; Return to Work; Operative Time; Hemorrhoidectomy; Hemorrhoids Third Degree; Hemorrhoids Fourth Degree
• Intervention / Treatment: Procedure: Hemorrhoidectomy

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CH(conventional Hemorrhoidectomy); conventional hemorrhoidectomy	Procedure: Hemorrhoidectomy; excision of 3rd and 4th degree hemorrhoids
Experimental: LH (Ligasure Hemorrhoidectomy); Ligasure hemorrhoidectomy	Procedure: Hemorrhoidectomy; excision of 3rd and 4th degree hemorrhoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	was measured from start of incision to the dressing in minutes	each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes
mean postoperative pain	on Visual analogue scale,a scale to assess the post operative pain ,8-10 as maximum pain, 5-7 as moderate pain, 2-4 minimum pain, 1-0 as no pain and change in final outcome has been assessed after 48 hours	each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours
wound healing	assessed in scheduled appointment every week and has been defined as complete epithelization on physical examination .Wound was graded as 1-sloughy, 2-no granulation, 3-granulation, 4-epithelizing , 5-completely epithelized	to assess change in the parameter in 3 weeks
Return to work	has been defined as day of discharge till resume of work that is patient is able to perform daily routine activities normally as before operation.	assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): September 30, 2014

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Visual Analogue pain score; conventional Hemorrhoidectomy; Ligasure Hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pain, Postoperative; Hemorrhoids
• Other Study ID Numbers: ServicesH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No