Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

Zagazig University

Status: Completed

Conditions: Anal Fissure; Inflammatory Bowel Diseases; Hemorrhoids

Treatments: Device: Laser; Procedure: traditional surgery; Procedure: treatment of anal diseases in inflammatory bowel patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06216223

#101080-5-9-2023

Details and patient eligibility

About

This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other.

Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis).
• Patients who accidently discovered to have inflammatory bowel disease.
• Age group between 18 to 60 years old

Exclusion criteria

• Informed consent refusal.
• Proved malignancy in inflammatory bowel disease patients
• Patients less than 18 years old or more than 60 years old
• Contraindications to general and spinal anesthesia
• other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

laser

Active Comparator group

Description:

laser ablation of anal diseases in inflammatory bowel patients

Treatment:

Device: Laser

Procedure: treatment of anal diseases in inflammatory bowel patients

traditional surgery

Sham Comparator group

Description:

traditional surgery for anal diseases in inflammatory bowel patients

Treatment:

Procedure: traditional surgery

Procedure: treatment of anal diseases in inflammatory bowel patients