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Completed

NCT Number: NCT06216223

Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

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.

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Key information

Conditions

Inflammatory Bowel Diseases Anal Fissure Anus Diseases Cardiovascular Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Fissure in Ano Gastroenteritis Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitals

Zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment of anal diseases in inflammatory bowel patients

Procedure

treatment of anal diseases in inflammatory bowel patients

laser

Device

laser

Traditional Surgery

Procedure

traditional surgery

Primary outcomes

  1. Operation time

    Time frame: Intraoperative (from skin incision to wound dressing.)

    operation time in minutes was studied between the 2 groups

  2. operative bleeding

    Time frame: Intraoperative to 2 weeks after operation.

    bleeding in cc was calculated between the 2 groups

  3. post operative anal discharge

    Time frame: from incision to 2 weeks after operation.

    presence of post operative anal discharge was detected in the 2 groups

  4. pain score with visual analogue scale

    Time frame: 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

  5. Healing time

    Time frame: 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

  6. Return to work

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

    Return to work after operation was studied between the 2 groups

  7. patient satisfaction score

    Time frame: 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

  8. Recurrence

    Time frame: detection of recurrence from 3 to 6 months after operation

    recurrence between 2 groups was assessed

  9. Fistula occurence

    Time frame: from 2 weeks to 2 months after operation

    fistula occurence studied between the 2 groups

  10. Stenosis

    Time frame: stenosis was detected from wound healing to 6 months later

    post operative stenosis between the 2 groups was studied

  11. Discharge from hospital

    Time frame: from one day post operative to one week

    hospital stay studied between the 2 groups

Secondary outcomes

  1. age

    Time frame: age of participants was recorded for one year duration of the study

    age in the 2 groups was studied

  2. sex

    Time frame: sex of participants was recorded for one year duration of the study

    sex was studied in the 2 groups

  3. specific disease

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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