Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

Not Applicable

Completed

• Conditions: Anal Fissure; Inflammatory Bowel Diseases; Hemorrhoids
• Interventions: Procedure: treatment of anal diseases in inflammatory bowel patients; Device: Laser; Procedure: traditional surgery

• Registration Number: NCT06216223
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser	Laser	laser ablation of anal diseases in inflammatory bowel patients
traditional surgery	traditional surgery	traditional surgery for anal diseases in inflammatory bowel patients
laser	treatment of anal diseases in inflammatory bowel patients	laser ablation of anal diseases in inflammatory bowel patients
traditional surgery	treatment of anal diseases in inflammatory bowel patients	traditional surgery for anal diseases in inflammatory bowel patients

Primary Outcome Measures

Name	Time	Method
pain score with visual analogue scale	from the 1st day to 2 weeks postoperatively	pain score with visual analogue scale was studied between the 2 groups,minimum score is 0 which means painless and maximum score is 10 which means very painful
Healing time	healing time was studies from the 1st day to 3 months after operation	time for complete healing after operation was studied between the 2 groups
Operation time	Intraoperative (from skin incision to wound dressing.)	operation time in minutes was studied between the 2 groups
operative bleeding	Intraoperative to 2 weeks after operation.	bleeding in cc was calculated between the 2 groups
post operative anal discharge	from incision to 2 weeks after operation.	presence of post operative anal discharge was detected in the 2 groups
Return to work	Return to work was assessed from one day to 2 months after surgery	Return to work after operation was studied between the 2 groups
patient satisfaction score	from one day to 3 months after operation	patient satisfaction score among patients in the 2 groups was studied using customer satisfaction score, minimum score is 1 means very dissatisfied and maximum score is 10 means very satisfied
Fistula occurence	from 2 weeks to 2 months after operation	fistula occurence studied between the 2 groups
Discharge from hospital	from one day post operative to one week	hospital stay studied between the 2 groups
Recurrence	detection of recurrence from 3 to 6 months after operation	recurrence between 2 groups was assessed
Stenosis	stenosis was detected from wound healing to 6 months later	post operative stenosis between the 2 groups was studied

Secondary Outcome Measures

Name	Time	Method
specific disease	diagnosis of diseases known 2 days before surgery from history	diagnosis of crohn's disease, ulcerative colitis, non specific colitis by colonoscopy and biopsy was done in the 2 groups
age	age of participants was recorded for one year duration of the study	age in the 2 groups was studied
sex	sex of participants was recorded for one year duration of the study	sex was studied in the 2 groups

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt