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

Primary Purpose

Postoperative Ileus

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Beetroot juice
Nitrate-depleted beetroot juice
Water
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Sham Comparator

Arm Label

Beetroot juice

Control group 1

Control group 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
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.

Full Information

First Posted
December 5, 2018
Last Updated
January 18, 2023
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03772444
Brief Title
Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
Acronym
BEET IT
Official Title
Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The pilot study was set up to assess whether the used dosing regimen of beetroot juice demonstrated to reach the therapeutic objective. The study was terminated early, as the deadline for the grant application for a larger study was approaching.
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beetroot juice
Arm Type
Active Comparator
Arm Title
Control group 1
Arm Type
Placebo Comparator
Arm Title
Control group 2
Arm Type
Sham Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate-depleted beetroot juice
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time until recovery of gastrointestinal function.
Description
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.
Time Frame
up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
Time Frame
up to 30 days after surgery
Title
Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
Time Frame
3 months postoperatively
Title
Presence of prolonged postoperative ileus.
Description
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.
Time Frame
up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ghent University Hospital
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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