Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Study Overview
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Brief Summary
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The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Detailed Description
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Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

Official Title
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Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Dietary Supplement: Beetroot juice
* Dietary Supplement: Nitrate-depleted beetroot juice
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All patients undergoing colonic or upper rectum laparoscopic surgery. Exclusion Criteria: Pregnancy or breast feeding Psychiatric pathology capable of affecting comprehension and judgment faculty History of metastatic disease History of prior abdominal bowel surgery Abdominal radiation treatment Chronic constipation (defined as two or fewer bowel movements per week) Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives) Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity More than one bowel anastomosis during this surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beetroot juice<br> | Dietary Supplement: Beetroot juice<br>* Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.<br>|
| Placebo Comparator: Control group 1<br> | Dietary Supplement: Nitrate-depleted beetroot juice<br>* Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.<br>|
| Sham Comparator: Control group 2<br> | Dietary Supplement: Water<br>* Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until recovery of gastrointestinal function. | Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food. | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days). |  | up to 30 days after surgery | 
| Overall post-operative complication rate defined according to the Clavien-Dindo Classification. |  | 3 months postoperatively | 
| Presence of prolonged postoperative ileus. | Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus. | up to 30 days after surgery |