Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Hemorrhoids; Anal Fissure
• Intervention / Treatment: Procedure: treatment of anal diseases in inflammatory bowel patients; Device: Laser; Procedure: traditional surgery

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laser; laser ablation of anal diseases in inflammatory bowel patients	Procedure: treatment of anal diseases in inflammatory bowel patients; treatment of anal diseases in inflammatory bowel patients; Device: Laser; laser
Sham Comparator: traditional surgery; traditional surgery for anal diseases in inflammatory bowel patients	Procedure: treatment of anal diseases in inflammatory bowel patients; treatment of anal diseases in inflammatory bowel patients; Procedure: traditional surgery; traditional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	operation time in minutes was studied between the 2 groups	Intraoperative (from skin incision to wound dressing.)
operative bleeding	bleeding in cc was calculated between the 2 groups	Intraoperative to 2 weeks after operation.
post operative anal discharge	presence of post operative anal discharge was detected in the 2 groups	from incision to 2 weeks after operation.
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
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
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
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
Recurrence	recurrence between 2 groups was assessed	detection of recurrence from 3 to 6 months after operation
Fistula occurence	fistula occurence studied between the 2 groups	from 2 weeks to 2 months after operation
Stenosis	post operative stenosis between the 2 groups was studied	stenosis was detected from wound healing to 6 months later
Discharge from hospital	hospital stay studied between the 2 groups	from one day post operative to one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	age in the 2 groups was studied	age of participants was recorded for one year duration of the study
sex	sex was studied in the 2 groups	sex of participants was recorded for one year duration of the study
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Reham Zakaria, PhD, Faculty of Medicine Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ulcerative colitis; inflammatory bowel disease; crohn's disease; anal fissure; hemorrhoids
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Gastroenteritis; Rectal Diseases; Anus Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Hemorrhoids; Fissure in Ano
• Other Study ID Numbers: #101080-5-9-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No