FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/08/035990 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 08/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare Harmonic Scalpel Surgery Versus Stapled Surgery For Management Of Hemorrhoids 
Scientific Title of Study   To compare the efficacy of harmonic scalpel haemorrhoidectomy versus stapled haemorrhoidopexy- a randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kshitij Jyoti 
Designation  Junior Resident - General Surgery 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Surgery, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  7022254051  
Fax    
Email  kjyoti@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  PP Rao 
Designation  Professor and HOD 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Surgery, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9464667808  
Fax    
Email  pankajrao@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dronacharya Routh 
Designation  Professor 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Surgery, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9464667808  
Fax    
Email  drona_routh@yahoo.co.in  
 
Source of Monetary or Material Support  
Dept of Surgery, Armed Forces Medical College, Pune, Maharashtra - 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College Pune 
Address  Dept of Surgery, Armed Forces Medical College, Pune, Maharashtra - 411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kshitij Jyoti  Command Hospital (Southern Command)  Department of Surgery, Command Hospital (Southern Command) Pune
Pune
MAHARASHTRA 
7022254051

kjyoti@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Armed Forces Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Harmonic Scalpel Hemorrhoidectomy  The hemorrhoidectomy will be performed using harmonic scalpel, in patients with grade 3 and grade 4 hemorrhoids. 
Intervention  Stapled Hemorrhoidectomy  The hemorrhoidectomy will be performed using hemorrhoidectomy staplers 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a) 18 years of age or older
b) Able to give informed consent
c) Adults with symptomatic grade 3 and 4 hemorrhoidal disease 
 
ExclusionCriteria 
Details  a) Patients with thrombosed/gangrenous haemorrhoids
b) Patients with deranged coagulation profile
c) Patients with presence of anal stenosis, perianal abscess and full thickness rectal prolapse
d) Those who had undergone previous anorectal surgery with resultant scarring of the anal canal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain assessment using visual analogue scale and requirement of analgesia  06hrs, 24 hrs, 36 hrs & 72 hrs post-operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Intra-operative blood loss (Weight of dry and wet Gauze piece)  Immediate post-op 
Operative time (Time Taken for completion of surgery)  Immediate post-op 
Post-operative complications (e.g. Bleeding per rectum, Faecal incontinence, Anal stenosis, Recurrence etc.)  6 months from surgery 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hemorrhoids, more commonly known as Piles, is one of the most common presentations in a surgical OPD. The term “hemorrhoids” was first used by Hippocrates and is derived from the Greek words “haima”, meaning blood, and “rhein”, meaning flow. The word “piles” was first used to describe the condition by John Ardene and is derived from the Latin word “pila” meaning ball. The theory of sliding anal canal lining is universally accepted as the basis of pathogenesis of hemorrhoids. This theory suggests the disintegration and deterioration of the supporting tissues of the anal cushions as the basis for development of hemorrhoids. Hemorrhoids can be thus be phrased as the pathological term to describe the abnormal downward displacement of the anal cushions causing venous dilatation. The abnormal dilatation and distortion of the vascular channel in conjugation with destructive changes in the supporting connective tissue within the anal cushion is one of the most important pathological findings of hemorrhoids.

Providing adequate care and a definitive treatment to patients has been a challenge for surgeons since antiquity. There are references of treatment of hemorrhoids using cautery by Hippocrates in the ancient times. This must have been an extremely painful ordeal through which the patients had to suffer, before the advent of anaesthesia. Today, the management of hemorrhoidal disease consists of multiple modalities, including dietary and bowel habit modifications, office procedures such as rubber-band ligation and sclerotherapy. Amongst the available surgical modalities, Hemorrhoidectomy is the most definitive treatment. 

The Harmonic Scalpel is a device that was first introduced in 1992. It uses ultrasonic energy for cutting tissue, where the blade vibrates at 55500 cycles per second, thereby denaturing the proteins in the tissue. It has been used extensively in many general surgery procedures as it causes minimal thermal damage to the surrounding tissues. Studies have indicated the benefits of harmonic scalpel hemorrhoidectomy over conventional excisional hemorrhoidectomy, owing to various factors like reduced postoperative pain, hospital stay and complications such as haemorrhage, urinary retention, stenosis and incontinence. 

Stapled hemorrhoidopexy, a procedure first described by Longo in 1998, has been rapidly emerging as one of the least painful procedures for treatment of hemorrhoids. The procedure involves application of purse-string sutures 3-4 cm above the dentate line, after the reduction of hemorrhoids following which the stapler device is deployed. After this, haemostasis is achieved by electrocautery or suture plication of the bleeding points at the stapled line. Studies have reported reduced post-operative pain and earlier covalence in patients undergoing this procedure, compared to conventional excisional hemorrhoidectomy.

The aim of this study is to compare the two aforementioned modalities in terms of post-operative pain, operating time, intra-operative bleeding, post-operative complications and recurrence rates. This will aid the decision-making process to determine the course of treatment to be offered to patients, and establish standard of care and management for patients suffering from grade 3 and 4 hemorrhoids.

 
Close