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

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.

Study Overview

• Status: Completed
• Conditions: Length of Stay; Operative Time; Hemorrhoidectomy; Third Degree Hemorrhoids; Fourth Degree Hemorrhoids; Postoperative,Pain
• Intervention / Treatment: Procedure: Hemorrhoidectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CH( Conventional Hemorrhoidectomy); Closed Conventional Hemorrhoidectomy	Procedure: Hemorrhoidectomy; Excision of third and fourth degree hemorrhoids; Other Names: Ferguson Closed Hemorrhoidectomy
Experimental: HS( Harmonic Scalpel); Harmonic Scalpel Hemorrhoidectomy	Procedure: Hemorrhoidectomy; Excision of third and fourth degree hemorrhoids; Other Names: Ferguson Closed Hemorrhoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	from start of incision to the dressing in minutes	The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes
post operative pain	On Visual analogue scale, a scale to measure pain and it ranges between 0-10. Scale 0-1 means no pain, 2-4 means mild pain,5-7 means moderate pain and 8-10 means severe pain. and it was measured post-operative in 24 hours	Each Patient was measured in 24 hours
Hospital Stay	was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)	the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore
• Investigators: Principal Investigator: Safia Z Ahmed, FCPS, Services Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2015
• Primary Completion (Actual): February 26, 2016
• Study Completion (Actual): February 28, 2016

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: VAS pain score; Harmonic Scalpel Hemorrhoidectomy; Conventional Hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: IRB/503/SIMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: I want to share the abstract to other researches
• IPD Sharing Time Frame: data is available as the study is complete and for 12 month period
• IPD Sharing Access Criteria: will be shared upon request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No