Preoperative PN Therapy in Malnourished Patients With IBD - A Randomized Controlled Trial

Primary Objective To determine the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the development of total post-operative complications.

Secondary Objectives To assess the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the incidence of post-operative infectious complications Primary Endpoint The primary endpoints will be the incidence of post-surgical complications in malnourished patients receiving pre-operative PN therapy compared with standard of care therapy Secondary Endpoints The secondary endpoints will be the cumulative incidence of post-operative infectious complications in IBD patients receiving surgery and hospital length of stay in patients receiving pre-operative PN therapy compared to standard of care nutritional therapy METHODS Study Design This is a prospective multi-center randomized controlled study. Allocation to either intervention or control group will be randomized based on blocks system (size of 4). The randomization sequence will be computer generated. Conjoint Ethics Review Board Approval for the study protocol will be sought in conventional manner.

Withdrawal Criteria

(a) If there is any catheter - related complications (including infection) resulting in catheter removal; (b) If the patient does not meet the goal therapeutic PN rate; (c) If the duration between the PN initiation and the surgery is less than 7 days (e.g. if the patient needed an emergency surgical intervention)

Recruitment and Consent The overwhelming majority of patients with IBD are admitted to the Gastroenterology Inpatient Service. As such, recruitment to this study will take a multi-pronged approach and be stream-lined. All Gastroenterologists and Gastroenterology (GI) Fellows in training at the FMC and PLC will be made aware of the protocol and as they are rounding, they will be aware to ask any eligible patients if they would be willing to speak with our research assistant about study participation. In addition, the research coordinator assigned to the study will review the inpatient electronic medical record, Sunrise Clinical Manager (SCM) daily to identify newly admitted inpatients to both study sites with IBD. The research coordinator will review the study eligibility of the newly admitted inpatients with the GI Fellows rotating on the GI service, and approach patients for protocol review and consent once deemed eligible. All participants will undergo prospective consenting via a written informed consent either by themselves or their family members.