Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Mansoura University

Status: Suspended

Conditions: Hemorrhoids

Treatments: Procedure: Hemorrhoidectomy; Drug: Trimebutine

Study type: Interventional

Funder types: Other

Identifiers

NCT03036111

mansourau20172

Details and patient eligibility

About

Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.

Full description

A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included

Exclusion criteria

• Patients with grade I/II internal hemorrhoids or external hemorrhoids.
• Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\
• Patients with recurrent hemorrhoids after previous surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Hemorrhoidectomy

Sham Comparator group

Description:

Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before

Treatment:

Procedure: Hemorrhoidectomy

trimebutine

Active Comparator group

Description:

Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.

Treatment:

Drug: Trimebutine

Procedure: Hemorrhoidectomy