Hemorrhoidectomy With or Without Lateral Internal Sphincterotomy in Management of Patients With Hemorrhoids

January 10, 2026 updated by: Abdelrahman Mohamed Salah, Minia University
This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proven to reduce the pain significantly.

However, there are many drawbacks to such techniques, such as postoperative pain and constipation. The cause of this postoperative pain is multifactorial. Spasm of the internal anal sphincter (IAS) is one of the factors which is exposed and impinged after EH. Therefore, Lateral internal sphincterotomy (LIS) is a widely used adjunct treatment after EH, which can abolish spasms of the IAS and subsequently relieve postoperative pain.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61611
        • Minia university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age above 18 years old.
  • Both sexes.
  • All patients indicated for surgical Hemorrhoidectomy (2nd, 3rd, and 4th degree piles).

Exclusion Criteria:

  • Patients with 1st degree piles.
  • Patients with piles plus fissure.
  • Age above 70 years old
  • Unfit for surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateral internal sphincterotomy group
Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.
Procedure: Hemorrhoidectomy with lateral internal sphincterotomy
Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.
Active Comparator: Control group
Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.
Procedure: Hemorrhoidectomy
Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anal pain score
Time Frame: 4 weeks postoperatively
The pain was measured by visual analog scoring (VAS) described as : 0-no pain, at score 1 to 3- mild pain, score 4 to 6-moderate pain, at score 7 to 10- severe pain. Post-operative pain was observed on subsequent visits after 48 hours, one week and 4 weeks postoperatively.
4 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of incontinence
Time Frame: 48 hours postoperatively.
Incontinence was assessed by Wexner's incontinence score for solid, liquid, and gas until 48 hours postoperatively
48 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1230/08/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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