Clinical trial NCT06216223: Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients
Official title: Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Anal Fissure
Hemorrhoids
Keywords: anal fissure
hemorrhoids
inflammatory bowel disease
crohn's disease
ulcerative colitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-01-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Operation time
timeFrame: Intraoperative (from skin incision to wound dressing.)
measure: operative bleeding
timeFrame: Intraoperative to 2 weeks after operation.
measure: post operative anal discharge
timeFrame: from incision to 2 weeks after operation.
measure: pain score with visual analogue scale
timeFrame: from the 1st day to 2 weeks postoperatively
measure: Healing time
timeFrame: healing time was studies from the 1st day to 3 months after operation
measure: Return to work
timeFrame: Return to work was assessed from one day to 2 months after surgery
measure: patient satisfaction score
timeFrame: from one day to 3 months after operation
measure: Recurrence
timeFrame: detection of recurrence from 3 to 6 months after operation
measure: Fistula occurence
timeFrame: from 2 weeks to 2 months after operation
measure: Stenosis
timeFrame: stenosis was detected from wound healing to 6 months later
measure: Discharge from hospital
timeFrame: from one day post operative to one week
Secondary outcomes:
measure: age
timeFrame: age of participants was recorded for one year duration of the study
measure: sex
timeFrame: sex of participants was recorded for one year duration of the study
measure: specific disease
timeFrame: diagnosis of diseases known 2 days before surgery from history
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
affiliation: faculty of medicine Zagazig University
name: Reham Zakaria, PhD
role: PRINCIPAL_INVESTIGATOR
References: