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

Not Applicable

Terminated

• Conditions: Postoperative Ileus
• Interventions: Dietary Supplement: Water; Dietary Supplement: Beetroot juice; Dietary Supplement: Nitrate-depleted beetroot juice

• Registration Number: NCT03772444
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group 2	Water	-
Beetroot juice	Beetroot juice	-
Control group 1	Nitrate-depleted beetroot juice	-

Primary Outcome Measures

Name	Time	Method
Time until recovery of gastrointestinal function.	up to 30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
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.	up to 30 days after surgery	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium