Comparison of Outcome of Injection Sclerotherapy Versus R... | NCT07199673

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

NCT07199673

Sponsor

Gulab Devi Hospital

Status

Completed

Last Update Posted

Jun 9, 2026Actual

Enrollment

128Actual

Phase

Not Applicable

Conditions

Hemorrhoid

Interventions

Injection Sclerotherapy
Rubber Band Ligation

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2025Actual

Primary Completion Date

Apr 6, 2026Actual

Completion Date

Apr 6, 2026Actual

First Submitted Date

Sep 19, 2025

First Submission Date that Met QC Criteria

Sep 26, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

There is a difference in the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early per rectal Bleeding	within 24 hours post-procedure	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Delayed Bleeding Per rectal	24 hours to 14th post-operative day	24 hours to 14th post operative day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulab devi Hospital Lahore		Lahore	Punjab Province	54600	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

i am collecting my data for study. I did not completed my data. so i am unable to share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided