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

Not Applicable

Recruiting

• Conditions: Lateral Internal Sphincterotomy; Hemorrhoidectomy; Hemorrhoids

• Registration Number: NCT06884774
• Lead Sponsor: Minia University

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.

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 Timeline

• Study Start: 2024-08-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-19
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anal pain score	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.

Secondary Outcome Measures

Name	Time	Method
Degree of incontinence	48 hours postoperatively.	Incontinence was assessed by Wexner's incontinence score for solid, liquid, and gas until 48 hours postoperatively

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt