| CTRI Number |
CTRI/2025/12/099870 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing a New Stitch-and-Laser Treatment With Traditional Methods for Painful Internal Piles (Hemorrhoids) |
|
Scientific Title of Study
|
M-C-LASER Trial: A randomized controlled trial comparing Chivates suture mucopexy combined with diode laser hemorrhoidoplasty versus sclerotherapy and Milligan-Morgan hemorrhoidectomy for symptomatic internal hemorrhoids. |
| Trial Acronym |
M-C-LASER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anowar Ali Mallick |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
| Address |
Department of General Surgery
5th floor, Ronald Ross Building
Institute of Post Graduate Medical Education and Research and SSKM Hospital
244, AJC Bose Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8001658748 |
| Fax |
|
| Email |
anowarcmc15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anowar Ali Mallick |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
| Address |
Department of General Surgery
5th floor, Ronald Ross Building
Institute of Post Graduate Medical Education and Research and SSKM Hospital
244, AJC Bose Road
WEST BENGAL
700020
India |
| Phone |
8001658748 |
| Fax |
|
| Email |
anowarcmc15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debaraj Shome Purkayastha |
| Designation |
Consultant |
| Affiliation |
Silchar Cancer Center |
| Address |
Department of Oncosurgery
Silchar Cancer Center
Silchar
Cachar
ASSAM
788003
India |
| Phone |
9615342162 |
| Fax |
|
| Email |
dspurkayastha@icloud.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research and SSKM Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Anowar Ali Mallick |
| Address |
Department of General Surgery
5th floor Ronald Ross Building
Institute of Post Graduate Medical Education and Research and SSKM Hospital
244 AJC Bose Road
Kolkata 700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Anowar Ali Mallick |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Unit IV
Department of General Surgery
244, AJC Bose Road
Kolkata
WEST BENGAL |
8001658748
anowarcmc15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
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: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chivate suture mucopexy with diode laser hemorrhoidoplasty
|
Participants allocated to the intervention arm will undergo Chivate suture mucopexy with diode laser hemorrhoidoplasty for symptomatic internal hemorrhoids (Goligher Grade II to IV). The procedure will be performed under appropriate anesthesia as per institutional protocol. Postoperative care and follow up will be standardized as per protocol.
|
| Comparator Agent |
Standard care for internal hemorrhoids based on Goligher grade |
Participants allocated to the comparator arm will receive standard care based on Goligher grade. Grade II will be treated with sclerotherapy using sodium tetradecyl sulfate three percent. Grade III and Grade IV will be treated with Milligan Morgan open hemorrhoidectomy. Postoperative care and follow up will be standardized as per protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 70 years.
Confirmed diagnosis of symptomatic internal hemorrhoids (Grade II, Grade III, or Grade IV by Goligher classification).
Able and willing to provide written informed consent and adhere to the study protocol. |
|
| ExclusionCriteria |
| Details |
Pregnancy.
Presence of portal hypertension, inflammatory bowel disease, or coagulopathy.
Use of anticoagulants that cannot be safely withheld.
Chronic high dose steroid use or immunocompromised status.
History of prior anorectal surgery. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean postoperative pain score measured by Visual Analog Scale from 0 to 10 |
6 hours, 24 hours, 48 hours, 72 hours post procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to return to normal activities in days
|
Post discharge diary until return to normal activities
|
Incidence of postoperative complications including bleeding infection urinary retention and others as recorded
|
From procedure until Day 30 Day 180 Day 365 follow up
|
Requirement for opioid analgesics
|
6 hours 24 hours 48 hours 72 hours and follow up at Day 30 Day 180 Day 365
|
Health related quality of life assessed using EQ 5D 5L questionnaire
|
Baseline and follow up at Day 30 Day 180 Day 365
|
Hemorrhoid recurrence rate
|
Day 180 and Day 365 follow up
|
Bowel continence assessed using Wexner incontinence score
|
Day 30 Day 180 Day 365 follow up
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anowarcmc15@gmail.com].
- For how long will this data be available start date provided 01-08-2028 and end date provided 31-07-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a single center prospective randomized controlled trial at the Department of General Surgery IPGMER and SSKM Hospital Kolkata India. Adults aged 18 to 70 years with symptomatic internal hemorrhoids Grade II III or IV by Goligher classification will be enrolled after written informed consent.
A total of 160 participants will be randomized in a 1 to 1 ratio using grade stratified randomization with variable block sizes and allocation concealment using sequentially numbered opaque sealed envelopes. Surgeons will be unblinded. Participants outcome assessors and data analysts will be blinded to treatment allocation.
Participants will be allocated to either an experimental arm or a control arm based on hemorrhoid grade. In the experimental arm patients will undergo Chivate suture mucopexy combined with diode laser hemorrhoidoplasty. In the control arm Grade II patients will undergo sclerotherapy with 3 percent sodium tetradecyl sulfate and Grade III to IV patients will undergo Milligan Morgan open hemorrhoidectomy.
The primary outcome is postoperative pain assessed using the Visual Analog Scale at 6 24 48 and 72 hours after the procedure. Secondary outcomes include time to return to normal activities postoperative complications including bleeding infection and urinary retention requirement for opioid analgesics health related quality of life using the EQ 5D 5L recurrence at 6 and 12 months and bowel continence using the Wexner Incontinence Score. Follow up visits are planned at Day 30 Day 180 and Day 365. |