RecruitingPhase 2NCT05133024

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

Sponsor

University Hospital, Ghent

Enrollment

170 participants

Start Date

Mar 31, 2021

Study Type

INTERVENTIONAL

Conditions

Postoperative Ileus

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

Min Age: 18 Years

Inclusion Criteria1

Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion

Exclusion Criteria25

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 mellitus
Renal or hepatic insufficiency
Known allergies or intolerances to beetroot, nitrates/nitrites
Enrollment in other clinical trials/experiments, unless approved by the Ethics Committee(s)
Surgical:
History of prior colorectal surgery
Emergency surgery
Open surgery
Colorectal surgery not requiring an anastomosis (e.g. colotomy, wedge resection)
More than 1 bowel anastomosis planned
Concomitant surgical procedures required (e.g. resection of liver or lung metastases)
Protective stoma planned