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Completed

NCT Number: NCT03848468

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

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Key information

Conditions

Hemorrhoidectomy Hemorrhoids Fourth Degree Hemorrhoids Third Degree Neurologic Manifestations Operative Time Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Return to Work Signs and Symptoms Wound Healing

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

services Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemorrhoidectomy

Procedure

excision of 3rd and 4th degree hemorrhoids

Primary outcomes

  1. operative time

    Time frame: each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes

    was measured from start of incision to the dressing in minutes

  2. mean postoperative pain

    Time frame: each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours

    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

  3. wound healing

    Time frame: to assess change in the parameter in 3 weeks

    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

  4. Return to work

    Time frame: assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days

    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.

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2019
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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