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A Study Comparing a New Stitch-and-Laser Treatment With Traditional Methods for Painful Internal Piles (Hemorrhoids)

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. - M-C-LASER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099870
Enrollment
160
Registered
2025-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K648- Other hemorrhoids

Interventions

Intervention1: Chivate suture mucopexy with diode laser hemorrhoidoplasty : Participants allocated to the intervention arm will undergo Chivate suture mucopexy with diode laser hemorrhoidoplasty for s

Sponsors

Dr Anowar Ali Mallick
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Mean postoperative pain score measured by Visual Analog Scale from 0 to 10Timepoint: 6 hours, 24 hours, 48 hours, 72 hours post procedure—

Secondary

MeasureTime frame
Time to return to normal activities in days Timepoint: Post discharge diary until return to normal activities ;Incidence of postoperative complications including bleeding infection urinary retention and others as recorded Timepoint: From procedure until Day 30 Day 180 Day 365 follow up ;Requirement for opioid analgesics Timepoint: 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 Timepoint: Baseline and follow up at Day 30 Day 180 Day 365 ;Hemorrhoid recurrence rate Timepoint: Day 180 and Day 365 follow up ;Bowel continence assessed using Wexner incontinence score Timepoint: Day 30 Day 180 Day 365 follow up—

Countries

India

Contacts

Public ContactDr Debaraj Shome Purkayastha

Institute of Post Graduate Medical Education and Research and SSKM Hospital

anowarcmc15@gmail.com8001658748

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026