Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery

NCT02260128 | Unknown

• 1 other identifier: Tyggegummi
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel function. This study evaluates whether chewing gum can reduce the bowel paralysis after surgery in patients undergoing either esophageal resection or whipples procedure. Half the study population will receive chewing gum while the other half will act as control.

Conditions

Cancer Esophagus; Pancreatic Cancer

Keywords

postoperative ileus; chewing gum

Outcome Measures

Primary Outcomes (2)

• Time from surgery to first flatus

  7 days

• Time from surgery to first defecation

  7 days

Study Arms (2)

Gum chewing

EXPERIMENTAL

This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes. Gum chewing is terminated when one of the primary end points occurs.

Other: Chewing gum

Control group

NO INTERVENTION

This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.

Interventions

Chewing gum OTHER

The intervention group will receive chewing gum four times daily following surgery.

Gum chewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing esophageal/cardial resection due to cancer and patients undergoing whipples procedure due to cancer.
• Macroradical resection must be accomplished.
• Informed consent given.

You may not qualify if:

• Patients WHO fail to follow the study regimen for more than 24 hours.
• Patients under the age of 18 years.
• Pregnant or beast feeding women.

Sponsors & Collaborators

• Michael Bau Mortensen: lead

Study Sites (1)

Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Pancreatic Neoplasms

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michael Bau Mortensen, Professor

  Departement of Surgery, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Lolle Norregaard, MD

CONTACT

004520949779; clnorregaard@gmail.com

Michael Bau Mortensen, Professor

CONTACT

michael.bau.mortensen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: October 9, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

DK (1)