Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

Inflammatory Bowel Diseases Clinical Trial

Official title:

Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216223
• Other study ID #: #101080-5-9-2023
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: April 5, 2024

Study information

• Verified date: May 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fissure
• Fissure in Ano
• Hemorrhoids
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• treatment of anal diseases in inflammatory bowel patients
treatment of anal diseases in inflammatory bowel patients

Device:
• Laser
laser

Procedure:
• traditional surgery
traditional surgery

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	operation time in minutes was studied between the 2 groups	Intraoperative (from skin incision to wound dressing.)
Primary	operative bleeding	bleeding in cc was calculated between the 2 groups	Intraoperative to 2 weeks after operation.
Primary	post operative anal discharge	presence of post operative anal discharge was detected in the 2 groups	from incision to 2 weeks after operation.
Primary	pain score with visual analogue scale	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	from the 1st day to 2 weeks postoperatively
Primary	Healing time	time for complete healing after operation was studied between the 2 groups	healing time was studies from the 1st day to 3 months after operation
Primary	Return to work	Return to work after operation was studied between the 2 groups	Return to work was assessed from one day to 2 months after surgery
Primary	patient satisfaction score	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	from one day to 3 months after operation
Primary	Recurrence	recurrence between 2 groups was assessed	detection of recurrence from 3 to 6 months after operation
Primary	Fistula occurence	fistula occurence studied between the 2 groups	from 2 weeks to 2 months after operation
Primary	Stenosis	post operative stenosis between the 2 groups was studied	stenosis was detected from wound healing to 6 months later
Primary	Discharge from hospital	hospital stay studied between the 2 groups	from one day post operative to one week
Secondary	age	age in the 2 groups was studied	age of participants was recorded for one year duration of the study
Secondary	sex	sex was studied in the 2 groups	sex of participants was recorded for one year duration of the study
Secondary	specific disease	diagnosis of crohn's disease, ulcerative colitis, non specific colitis by colonoscopy and biopsy was done in the 2 groups	diagnosis of diseases known 2 days before surgery from history