CompletedNot Applicable

Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

Egypt108 participantsStarted 2023-09-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Operation time

Timeframe: Intraoperative (from skin incision to wound dressing.)

operative bleeding

Timeframe: Intraoperative to 2 weeks after operation.

post operative anal discharge

Timeframe: from incision to 2 weeks after operation.

pain score with visual analogue scale

Timeframe: from the 1st day to 2 weeks postoperatively

Healing time

Timeframe: healing time was studies from the 1st day to 3 months after operation

Return to work

Timeframe: Return to work was assessed from one day to 2 months after surgery

patient satisfaction score

Timeframe: from one day to 3 months after operation

Trial details

NCT IDNCT06216223

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-04-05

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials