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

NCT ID: NCT06884774

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Lateral Internal Sphincterotomy Hemorrhoidectomy Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lateral internal sphincterotomy group

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Group Type EXPERIMENTAL

Hemorrhoidectomy with lateral internal sphincterotomy

Intervention Type PROCEDURE

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Control group

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Group Type ACTIVE_COMPARATOR

Hemorrhoidectomy

Intervention Type PROCEDURE

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Interventions

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Hemorrhoidectomy with lateral internal sphincterotomy

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Intervention Type PROCEDURE

Hemorrhoidectomy

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mohamed Salah

Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1230/08/2024

Identifier Type: -

Identifier Source: org_study_id

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