Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

NCT ID: NCT06216223

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-04-05

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases Anal Fissure Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laser

laser ablation of anal diseases in inflammatory bowel patients

Group Type ACTIVE_COMPARATOR

treatment of anal diseases in inflammatory bowel patients

Intervention Type PROCEDURE

treatment of anal diseases in inflammatory bowel patients

Laser

Intervention Type DEVICE

laser

traditional surgery

traditional surgery for anal diseases in inflammatory bowel patients

Group Type SHAM_COMPARATOR

treatment of anal diseases in inflammatory bowel patients

Intervention Type PROCEDURE

treatment of anal diseases in inflammatory bowel patients

traditional surgery

Intervention Type PROCEDURE

traditional surgery

Interventions

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treatment of anal diseases in inflammatory bowel patients

treatment of anal diseases in inflammatory bowel patients

Intervention Type PROCEDURE

Laser

laser

Intervention Type DEVICE

traditional surgery

traditional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reham Zakaria Mohamed Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham Zakaria, PhD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine Zagazig University

Locations

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Zagazig University Hospitals

Zagazig, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39511001 (View on PubMed)

Other Identifiers

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#101080-5-9-2023

Identifier Type: -

Identifier Source: org_study_id

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