Effects of Chewing Gum Against Postoperative Ileus

NCT02319512 | Terminated Phase 3 DMC

• 2 other identifiers: 1818111VGFOUGSB-1818111
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (2)

• First flatus after surgery

  From day of surgery until first postoperative flatus (with in the first 21 days)

• First stool after surgery

  From day of surgery until first stool (with in the first 21 days)

Secondary Outcomes (3)

• Start of clear fluids

  From day of surgery until start of clear liquids after surgery (with in the first 21 days)

• Start of liquid diet

  From day of surgery until start of liquid diet after surgery (with in the first 21 days)

• Length of hospital stay

  From day of surgery until discharge from surgical ward (with in the first 21 days)

Study Arms (2)

Chewing gum

EXPERIMENTAL

Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay.

Other: Chewing gum

Control

SHAM COMPARATOR

Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum

Other: Glucose

Interventions

Chewing gum OTHER

ChiczaTM organic chewing gum 6 pieces a day

Chewing gum

Glucose OTHER

12ml glucose solution (13,6g) per day

Control

Eligibility Criteria

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

You may qualify if:

• Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
• Understand and speak swedish
• No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function
• No ongoing treatment for mental disease
• No ongoing abuse of alcohol or other drugs
• No previously known allergies to the content of chewing gum

You may not qualify if:

• Additional surgery after primary surgery.
• No radical curative surgery
• Previous abdominal surgery.

Sponsors & Collaborators

• Thomas Andersson: lead

Related Publications (1)

• Andersson T, Bjersa K, Falk K, Olsen MF. Effects of chewing gum against postoperative ileus after pancreaticoduodenectomy--a randomized controlled trial. BMC Res Notes. 2015 Feb 10;8:37. doi: 10.1186/s13104-015-0996-0.

  PMID: 25886536 DERIVED

MeSH Terms

Interventions

Chewing Gum; Glucose

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; Hexoses; Monosaccharides; Sugars

Study Officials

• Kristin Falk, PhD

  Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden

  STUDY DIRECTOR

• Monika Fagevik Olsén, PhD

  Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden

  STUDY DIRECTOR

• Kristofer Bjerså, PhD

  Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• Thomas Andersson, MSc

  Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN, CNS, MSc

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 18, 2014
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 18, 2014

Record last verified: 2014-12