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Recruiting Phase 2 NCT05133024

Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

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Trial Parameters

Condition Postoperative Ileus
Sponsor University Hospital, Ghent
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-03-31
Completion 2026-09-30
Interventions
concentrated beetroot juice

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Brief Summary

The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.

Eligibility Criteria

Inclusion Criteria: * Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion Exclusion Criteria: General: * \< 18 years of age * Pregnancy or breast feeding Medical: * Psychiatric pathology capable of affecting comprehension and judgment faculty * History of inflammatory bowel disease * Chronic vascular disease affecting the intestines * Chronic constipation (\<= 2 bowel movements/week) * Previous abdominal or pelvic radiation treatment * Recent (\< 3 months before inclusion) or current intra-abdominal infection or inflammation (e.g. diverticulitis, appendicitis, cholecystitis) * Use of gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives) * Use of nitrates (e.g. isosorbide dinitrate, nitroglycerin), including daily consumption of beetroot juice (unless stopped for a month prior to the intervention period) * Hypotension (\< 100/60 mmHg) * Uncontrolled diabetes mellitu

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