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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848468
• Other study ID #: ServicesH
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: September 30, 2014

Study information

• Verified date: February 2019
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Hemorrhoidectomy
excision of 3rd and 4th degree hemorrhoids

Locations

Country	Name	City	State
Pakistan	services Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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