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

Primary Purpose

Hemorrhoidectomy, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hemorrhoidectomy
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoidectomy focused on measuring Visual Analogue pain score, conventional Hemorrhoidectomy, Ligasure Hemorrhoidectomy

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • services Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CH(conventional Hemorrhoidectomy)

LH (Ligasure Hemorrhoidectomy)

Arm Description

conventional hemorrhoidectomy

Ligasure hemorrhoidectomy

Outcomes

Primary Outcome Measures

operative time
was measured from start of incision to the dressing in 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
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
February 19, 2019
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT03848468
Brief Title
Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Official Title
Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
September 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoidectomy, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Operative Time, Pain, Postoperative, Wound Healing, Return to Work
Keywords
Visual Analogue pain score, conventional Hemorrhoidectomy, Ligasure Hemorrhoidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Covidien 5mm ligasure
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CH(conventional Hemorrhoidectomy)
Arm Type
Active Comparator
Arm Description
conventional hemorrhoidectomy
Arm Title
LH (Ligasure Hemorrhoidectomy)
Arm Type
Experimental
Arm Description
Ligasure hemorrhoidectomy
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidectomy
Intervention Description
excision of 3rd and 4th degree hemorrhoids
Primary Outcome Measure Information:
Title
operative time
Description
was measured from start of incision to the dressing in minutes
Time Frame
each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes
Title
mean postoperative pain
Description
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
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
Title
wound healing
Description
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
Time Frame
to assess change in the parameter in 3 weeks
Title
Return to work
Description
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.
Time Frame
assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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