Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients

NCT01583452 | Completed Phase 1 Results DMC

• 1 other identifier: UGoMaRIPO
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Post- operative ileus refers to the time after surgery before coordinated electromotor bowel function resumes. It's treatment and prevention may signify an elevated hospitalization cost and the exposure to the patient to adverse effects of drugs. The current clinical trial has as primary objective to prove the efficacy of chewing gum as a preventive measure of post-operative ileus in pediatric patients after gastrointestinal surgery through the determination of the time the patient takes to tolerate oral intake, pass flatus, present bowel movements and the time of hospital stay. Patients will be assigned either to the case group (chewing gum + standard treatment) or to the control group (standard treatment), in both of them time from the end of surgery to the moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any type of food) and is discharged from hospital; will be measured in hours and then analyzed to determine the validity of these data.

Conditions

Post Operative Ileus

Keywords

Post operative ileus; Gastrointestinal surgery; Chewing gum

Outcome Measures

Primary Outcomes (1)

• Post-Operative Hospital Stay

  The time between the end of surgery and hospital discharge, measured in hours

  End of surgery to hospital discharge (from 4 to 7 days)

Secondary Outcomes (3)

• Time to First Flatus

  End of surgery to first flatus (from 1 to 3 days)

• Time to First Bowel Movement

  End of surgery to first bowel motion (from 1 to 7 days)

• Time to Tolerate Feedings (Oral Intake)

  End of surgery to oral intake tolerance (from 1 to 3 days)

Study Arms (2)

Chewing Gum Group

EXPERIMENTAL

Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.

Other: Chewing Gum

No intervention

NO INTERVENTION

By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.

Interventions

Chewing Gum OTHER

The use of chewing gum as a preventive measure for post-operative ileus

Also known as: Sugarless chewing gum, Trident, Orbit, Ice Breakers, Smint

Chewing Gum Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients who underwent any type of gastrointestinal surgery.

You may not qualify if:

• Patients unable to chew
• Patients unable to swallow
• Patients whose clinical status is critical
• Patients with gastrointestinal motility disorders not associated with GI surgeries.
• Patients unable to follow directions about the use of chewing gum

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

Hospital San Jose Tec de Monterrey

Monterrey, Nuevo León, 64710, Mexico

Location

Related Publications (6)

• Vasquez W, Hernandez AV, Garcia-Sabrido JL. Is gum chewing useful for ileus after elective colorectal surgery? A systematic review and meta-analysis of randomized clinical trials. J Gastrointest Surg. 2009 Apr;13(4):649-56. doi: 10.1007/s11605-008-0756-8. Epub 2008 Dec 3.

  PMID: 19050983 BACKGROUND

• Johnson MD, Walsh RM. Current therapies to shorten postoperative ileus. Cleve Clin J Med. 2009 Nov;76(11):641-8. doi: 10.3949/ccjm.76a.09051.

  PMID: 19884293 BACKGROUND

• Purkayastha S, Tilney HS, Darzi AW, Tekkis PP. Meta-analysis of randomized studies evaluating chewing gum to enhance postoperative recovery following colectomy. Arch Surg. 2008 Aug;143(8):788-93. doi: 10.1001/archsurg.143.8.788.

  PMID: 18711040 BACKGROUND

• de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21.

  PMID: 18292660 BACKGROUND

• Noble EJ, Harris R, Hosie KB, Thomas S, Lewis SJ. Gum chewing reduces postoperative ileus? A systematic review and meta-analysis. Int J Surg. 2009 Apr;7(2):100-5. doi: 10.1016/j.ijsu.2009.01.006. Epub 2009 Jan 31.

  PMID: 19261555 BACKGROUND

• Fitzgerald JE, Ahmed I. Systematic review and meta-analysis of chewing-gum therapy in the reduction of postoperative paralytic ileus following gastrointestinal surgery. World J Surg. 2009 Dec;33(12):2557-66. doi: 10.1007/s00268-009-0104-5.

  PMID: 19763686 BACKGROUND

MeSH Terms

Interventions

Chewing Gum; Forkhead Box Protein M1

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; Forkhead Transcription Factors; Winged-Helix Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Limitations and Caveats

We had a small number of participants because of time limitations. We included only patients with diagnosis of appendicitis and post-op appendectomy.

Results Point of Contact

• Title: Gabriela López Jaimez
• Organization: ITESM - Pediatrics Division

gabylopez7@gmail.com

+527211476044

Study Officials

• Gabriela Lopez, MD

  Instituto Tecnologico y de Estudios Superiores de Monterey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrics Resident

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-06

Locations

ME (1)