The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03747068
• Date of registration: 12/11/2018
• Prospective Registration: No
• Primary sponsor: HaEmek Medical Center, Israel
• Public title: The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.
• Scientific title: Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis
• Date of first enrolment: October 9, 2009
• Target sample size: 130
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03747068
• Study type: Observational

Key inclusion & exclusion criteria

Inclusion Criteria:

- all individuals with IBD who underwent IPAA from January 2002 to June 2013 were
reviewed .

Exclusion Criteria:

- Patients with CD

- Patients without adequate clinical records documenting the 30-day postoperative
clinical outcomes .



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ileal Pouch Anal Anastomosis (IPAA)

Anti TNF Therapy

Ulcerative Colitis

Intervention(s)

Drug: Anti-TNF Drug

Primary Outcome(s)

to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery [Time Frame: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed]

Secondary ID(s)

09-0218-E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Toronto

Mount Sinai Hospital, Canada