Comparison of Outcome of Injection Sclerotherapy Versus Rubber Band Ligation for Second Degree Hemorrhoids

NCT07199673 | Active Not Recruiting

• 1 other identifier: AAMC/IRB/EA252025
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of this study is to compare the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.

Conditions

Hemorrhoid

Keywords

Injection Sclerotherapy; Rubber Band Ligation; Second Degree Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Early per rectal Bleeding

  within 24 hours post-procedure

  24 hours

Secondary Outcomes (1)

• Delayed Bleeding Per rectal

  24 hours to 14th post operative day

Study Arms (2)

Group IST

OTHER

5% phenol in almond oil

Drug: Injection Sclerotherapy

Group RBL

OTHER

rubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps.

Device: Rubber Band Ligation

Interventions

Injection Sclerotherapy DRUG

identifying the hemorrhoidal pedicle, 3-5 ml of 5% phenol in almond oil is injected into the submucosal plane of the hemorrhoid pedicle

Group IST

Rubber Band Ligation DEVICE

knee-elbow position is used. After identifying the hemorrhoids with a proctoscope, a rubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps.

Group RBL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18 and 75 who have been diagnosed with second-degree hemorrhoids

You may not qualify if:

• Patients with thrombosed hemorrhoids, and those with serious comorbid conditions such as heart, kidney, or liver diseases, coagulation disorders, or severe anemia.
• Individuals who have received treatment for hemorrhoids in the past six months.
• Pregnant women.
• Patients unable to commit to necessary follow-up appointments.
• Patients with a history or current presence of colorectal cancer or anal malignancy.

Sponsors & Collaborators

• Gulab Devi Hospital: lead

Study Sites (1)

Gulab devi Hospital Lahore

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduation Resident

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 30, 2025
• Study Start: July 7, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)