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

NCT ID: NCT03938714

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-27
• Study Completion Date: 2016-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CH( Conventional Hemorrhoidectomy)

Closed Conventional Hemorrhoidectomy

Group Type: ACTIVE_COMPARATOR

Hemorrhoidectomy

Intervention Type: PROCEDURE

Excision of third and fourth degree hemorrhoids

HS( Harmonic Scalpel)

Harmonic Scalpel Hemorrhoidectomy

Group Type: EXPERIMENTAL

Hemorrhoidectomy

Intervention Type: PROCEDURE

Excision of third and fourth degree hemorrhoids

Interventions

Hemorrhoidectomy

Excision of third and fourth degree hemorrhoids

Intervention Type: PROCEDURE

Other Intervention Names

Ferguson Closed Hemorrhoidectomy

Eligibility Criteria

Inclusion Criteria

• Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.

Exclusion Criteria

• • Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy

• Any other anorectal pathology such as anal fissure ,fistula or anal cancer on history and per rectal examination
• Previous anal surgery assessed by history and per rectal examination
• Inability to give informed consent
• ASA grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic(AST/ALT >40IU/L) and renal profile ( creatinine >1:2mg/dl)and evidence of ischemic heart disease(annexure attached).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Services Hospital, Lahore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Safia Zahir Ahmed

principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Safia Z Ahmed, FCPS

Role: PRINCIPAL_INVESTIGATOR

Services Hospital

Locations

services Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB/503/SIMS

Identifier Type: -

Identifier Source: org_study_id