NCT03938714

Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Services Hospital, Lahore · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Hemorrhoidectomy is the treatment of choice for grade 3 and 4th degree hemorrhoids. Various surgical technique has been used to improve the outcome of the procedures performed in respect to operative time ,post operative pain and hospital stay. This study compares the conventional closed technique with harmonic scalpel technique which is a device regulated with ultrasonic waves to perform the procedure with minimal postoperative complication as well as decreasing the prolong stay in hospital.

Detailed description

INTRODUCTION: Ferguson closed hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in harmonic scalpel have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time and duration of hospital stay. OBJECTIVES: To compare the outcome of conventional hemorrhoidectomy versus harmonic scalpel 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 27th August 2015 to 26th February 2016. DATA COLLECTION PROCEDURE: After approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria had 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: harmonic scalpel hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures had been performed by a single surgical operating team to control bias. Per operatively operative time was noted. Post operatively pain had been assessed in 24 hours , mean hospital stay was measured in days from postoperative day till day of discharge (as per operational definition). All data had been collected and recorded on the attached Performa.

Conditions

• Hemorrhoidectomy
• Third Degree Hemorrhoids
• Fourth Degree Hemorrhoids
• Operative Time
• Postoperative,Pain
• Length of Stay

Interventions

Type	Name	Description
PROCEDURE	Hemorrhoidectomy	Excision of third and fourth degree hemorrhoids

Timeline

• Start date: 2015-08-27
• Primary completion: 2016-02-26
• Completion: 2016-02-28
• First posted: 2019-05-06
• Last updated: 2019-05-06

Locations

1 site across 1 country: Pakistan