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

Minia University

Status: Completed

Conditions: Lateral Internal Sphincterotomy; Hemorrhoidectomy; Hemorrhoids

Treatments: Procedure: Hemorrhoidectomy with lateral internal sphincterotomy; Procedure: Hemorrhoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06884774

1230/08/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Lateral internal sphincterotomy group

Experimental group

Description:

Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.

Treatment:

Procedure: Hemorrhoidectomy with lateral internal sphincterotomy

Control group

Active Comparator group

Description:

Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.

Treatment:

Procedure: Hemorrhoidectomy