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

NCT06884774 | Completed

• 1 other identifier: 1230/08/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.

Conditions

Lateral Internal Sphincterotomy; Hemorrhoidectomy; Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Anal pain score

  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 Outcomes (1)

• Degree of incontinence

  48 hours postoperatively.

Study Arms (2)

Lateral internal sphincterotomy group

EXPERIMENTAL

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Procedure: Hemorrhoidectomy with lateral internal sphincterotomy

Control group

ACTIVE COMPARATOR

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Procedure: Hemorrhoidectomy

Interventions

Hemorrhoidectomy PROCEDURE

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Control group

Hemorrhoidectomy with lateral internal sphincterotomy PROCEDURE

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Lateral internal sphincterotomy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61611, Egypt

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Hemorrhoidectomy; Lateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: December 20, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)