Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

NCT06216223 | Completed

• 1 other identifier: #101080-5-9-2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Anal Fissure; Hemorrhoids

Keywords

anal fissure; hemorrhoids; inflammatory bowel disease; crohn's disease; ulcerative colitis

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• age

  age of participants was recorded for one year duration of the study

• sex

  sex of participants was recorded for one year duration of the study

• specific disease

  diagnosis of diseases known 2 days before surgery from history

Study Arms (2)

laser

ACTIVE COMPARATOR

laser ablation of anal diseases in inflammatory bowel patients

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

traditional surgery

SHAM COMPARATOR

traditional surgery for anal diseases in inflammatory bowel patients

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

Interventions

treatment of anal diseases in inflammatory bowel patients PROCEDURE

treatment of anal diseases in inflammatory bowel patients

laser; traditional surgery

Laser DEVICE

laser

laser

traditional surgery PROCEDURE

traditional surgery

traditional surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, 44519, Egypt

Location

Related Publications (1)

• Zakaria R, Amin MM, Abo-Alella HA, Hegab YH. Laser hemorrhoidoplasty versus hemorrhoidectomy in the treatment of surgically indicated hemorrhoids in inflammatory bowel patients: a randomized comparative clinical study. Surg Endosc. 2025 Jan;39(1):249-258. doi: 10.1007/s00464-024-11351-3. Epub 2024 Nov 7.

  PMID: 39511001 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fissure in Ano; Hemorrhoids; Crohn Disease; Colitis, Ulcerative

Interventions

Lasers

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Vascular Diseases; Cardiovascular Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Reham Zakaria, PhD

  faculty of medicine Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 22, 2024
• Study Start: September 5, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

EG (1)