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

NCT03772444 | Terminated DMC

• 1 other identifier: EC/2017/1476
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Beetroot juice

ACTIVE COMPARATOR

Dietary Supplement: Beetroot juice

Control group 1

PLACEBO COMPARATOR

Dietary Supplement: Nitrate-depleted beetroot juice

Control group 2

SHAM COMPARATOR

Dietary Supplement: Water

Interventions

Beetroot juice DIETARY_SUPPLEMENT

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.

Beetroot juice

Nitrate-depleted beetroot juice DIETARY_SUPPLEMENT

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.

Control group 1

Water DIETARY_SUPPLEMENT

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.

Control group 2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing colonic or upper rectum laparoscopic surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (\~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: January 15, 2018
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)