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
|
|
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
|
|
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 “haimaâ€, meaning blood, and “rheinâ€, 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. |