title: Obtaining research biopsies during pediatric colonoscopy: Safety and adverse events.
abstract: OBJECTIVE
  To investigate the safety profile of acquiring additional intestinal biopsies for research purposes in children undergoing a medically indicated colonoscopy.
  
  
  METHODS
  A retrospective review of 122 pediatric patients who underwent colonoscopy over a 9 mo time period was completed. 38/122 participants consented to a research study in which 4 additional biopsies were obtained, in addition to routine biopsies. The outcomes after colonoscopy were measured in the research participants, and compared to 84 control participants who did not consent for the study. Groups were compared with regard to number of biopsies obtained, underlying diagnosis, and both serious and minor adverse outcomes. Data was collected including: age, gender, race, indication, diagnosis, number of biopsies obtained per case and post procedure adverse events. Medical records were reviewed and a questionnaire was completed by each of the ten gastroenterologists who performed procedures during the study. Physicians were asked about individual patient outcomes to ensure that all adverse events, such as perforation, excessive bleeding, infection, and minor gastrointestinal outcomes, were captured and included.
  
  
  RESULTS
  The research group had more biopsies obtained (mean = 13.58 ± 4.21) compared to controls (mean = 9.33 ± 4.40), P ≤ 0.0001, however there was no difference in adverse events. Serious outcomes, defined as perforation, bleeding and infection, did not occur, in either group. As such, the relationship between serious adverse events and number of biopsies obtained was not determined. Minor gastrointestinal outcomes, such as abdominal pain, diarrhea or vomiting, were reported in 21 patients (8 research participants and 13 control participants) however the incidence of minor gastrointestinal outcomes between the two groups did not vary significantly, P = 0.45. Additionally, the mean number of biopsies obtained in patients who had a minor outcome (mean = 12.1 ± 0.77), compared to those with no adverse outcome (mean = 10.34 ± 0.5), revealed no statistical difference between the groups (P = 0.12), suggesting that number of biopsies is not associated with incidence of minor adverse events.
  
  
  CONCLUSIONS
  Patients participating in research requiring acquisition of additional biopsies for research purposes alone, are not at an increased risk of adverse outcomes.
authors.affiliation: Jennifer Mait-Kaufman, Gitit Tomer, Department of Pediatric Gastroenterology and Nutrition, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY 10467, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Mait-Kaufman
authors.affiliation: Jennifer Mait-Kaufman, Gitit Tomer, Department of Pediatric Gastroenterology and Nutrition, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY 10467, United States.
authors.forename: Stacie
authors.initials: S
authors.lastname: Kahn
authors.affiliation: Jennifer Mait-Kaufman, Gitit Tomer, Department of Pediatric Gastroenterology and Nutrition, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY 10467, United States.
authors.forename: Gitit
authors.initials: G
authors.lastname: Tomer
keywords: Intestinal biopsy; Outcomes; Pediatric colonoscopy; Research; Safety