Anal Fissure, Hemorrhoids, Inflammatory Bowel Diseases
Conditions
Keywords
anal fissure, hemorrhoids, inflammatory bowel disease, crohn's disease, ulcerative colitis
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.
Interventions
PROCEDUREtreatment of anal diseases in inflammatory bowel patients
treatment of anal diseases in inflammatory bowel patients
DEVICELaser
laser
PROCEDUREtraditional surgery
traditional surgery
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge from hospital | from one day post operative to one week | hospital stay studied between the 2 groups |
| Recurrence | detection of recurrence from 3 to 6 months after operation | recurrence between 2 groups was assessed |
| Fistula occurence | from 2 weeks to 2 months after operation | fistula occurence studied between the 2 groups |
| Stenosis | stenosis was detected from wound healing to 6 months later | post operative stenosis between the 2 groups was studied |
| Operation time | Intraoperative (from skin incision to wound dressing.) | operation time in minutes was studied between the 2 groups |
| operative bleeding | Intraoperative to 2 weeks after operation. | bleeding in cc was calculated between the 2 groups |
| post operative anal discharge | from incision to 2 weeks after operation. | presence of post operative anal discharge was detected in the 2 groups |
| pain score with visual analogue scale | from the 1st day to 2 weeks postoperatively | 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 |
| Healing time | healing time was studies from the 1st day to 3 months after operation | time for complete healing after operation was studied between the 2 groups |
| Return to work | Return to work was assessed from one day to 2 months after surgery | Return to work after operation was studied between the 2 groups |
| patient satisfaction score | from one day to 3 months after operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sex | sex of participants was recorded for one year duration of the study | sex was studied in the 2 groups |
| specific disease | diagnosis of diseases known 2 days before surgery from history | diagnosis of crohn's disease, ulcerative colitis, non specific colitis by colonoscopy and biopsy was done in the 2 groups |
| age | age of participants was recorded for one year duration of the study | age in the 2 groups was studied |
Countries
Egypt
Outcome results
None listed