| CTRI Number |
CTRI/2026/02/103944 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Harmonic Scalpel and Conventional Surgery in the Treatment of Hemorrhoids |
|
Scientific Title of Study
|
“A Comparative Study of Harmonic Scalpel Versus Milligan–Morgan Technique in the Surgical Management of Hemorrhoids” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NADUPURI RENUKA NAIDU |
| Designation |
POST GRADUATE |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
CHINNASIRAGAPADI
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
8519889534 |
| Fax |
|
| Email |
renukanadupuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUN BALAJI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
CHINNASIRAGAPADI
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
8124555000 |
| Fax |
|
| Email |
drarunbalaji87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NADUPURI RENUKA NAIDU |
| Designation |
POST GRADUATE |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
CHINNASIRAGAPADI
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
8519889534 |
| Fax |
|
| Email |
renukanadupuri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARMENT OF GENERAL SURGERY |
| Address |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
CHINNASEERAGAPADI
SALEM |
| Type of Sponsor |
Private 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 |
| NADUPURI RENUKA NAIDU |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
CHINNASIRAGAPADI
Salem
TAMIL NADU |
8519889534
renukanadupuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Group A
Intervention Name:
Harmonic Scalpel Haemorrhoidectomy |
Intervention Details:
Patients allocated to this group will undergo hemorrhoidectomy using the harmonic scalpel. The procedure will be performed under regional or general anesthesia following standard aseptic precautions. Excision of hemorrhoidal tissue will be carried out using the harmonic scalpel, which allows simultaneous cutting and coagulation. Hemostasis will be achieved using the same device without the use of conventional sutures. Postoperative care will be provided as per institutional protocol. |
| Intervention |
Intervention Group B
Intervention Name:
Milligan–Morgan Hemorrhoidectomy (Conventional Open Technique) |
Intervention Details:
Patients allocated to this group will undergo conventional open hemorrhoidectomy using the Milligan–Morgan technique. The procedure will be performed under regional or general anesthesia following standard aseptic precautions. Hemorrhoidal tissue will be excised using scissors or electrocautery, with ligation of the pedicle using absorbable sutures. Hemostasis will be secured, and standard postoperative care will be given as per institutional protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with grade III or Grade IV hemorrhoids
Fit for surgery under spinal or General anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with coexisting anorectal conditions
Bleeding diathesis or on anticoagulants
Immunocompromised
History of previous anorectal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreased postoperative pain
Decreased operation time
Reduced intraoperative bleeding
Reduced complications rates
Lesser recurrence rate
Faster wound healing
Reduced post operative pain
Reduced healing time |
Postoperative Pain
Assessment of postoperative pain using Visual Analogue Scale (VAS) score
Pain is the most important and consistently compared outcome between harmonic scalpel and Milligan–Morgan techniques
Time Points for Primary Outcome Assessment
Postoperative pain will be assessed at the following time points:
6 hours post-surgery
24 hours post-surgery
48 hours post-surgery
7th postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/02/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Haemorrhoids are a common anorectal disorder often requiring surgical intervention in advanced grades .The conventional milligan - morgan haemorrhoidectomy is widely praticed but is associated with significant postoperative pain,bleedig,and longer recovery.The harmonic scalpel,which uses ultrasonic energy for cutting and coagulation,has been introduced as an alternative technique with the potential advantages of minimal tissue trauma and better haemostasis.This study aims to compare harmonic scalpel haemorrhoidectomy with the milligan - morgan technique in terms of operative time,intraoperative blood loss,postoperative pain,complications(bleeding,urinary retention,infection),duration of hospital stay,and time to return to normal activities.The outcomes of this comparative study will help determine whether the harmonic scalpel offers significant clinical benefits over the conventional technique in the management of haemorrhoids. |