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

Post Operative Ileus Clinical Trial

Official title:

Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583452
• Other study ID #: UGoMaRIPO
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2012
• Last updated: June 27, 2015
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: June 2015
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Postoperative ileus is a relatively common condition seen in patients with gastrointestinal diseases requiring surgery. Treatment and prevention of this condition involves the use of several drugs and devices which increase the length of hospital stay, costs of treatment and morbidity.

In the last years there have been several reports about the use of chewing gum as a preventive measure of postoperative ileus with positive results in the adult population. Most of these studies involve patients who underwent colectomy. In the bibliographic review the investigators found just one study developed specifically with pediatric patients. Results are very similar between the studies; time to present first bowel movement, pass flatus and tolerate oral intake is decreased with statistically significant evidence, meanwhile, the length of hospital stay has been proved to be shortened in just a few studies.

The primary objective in the investigators study is to demonstrate chewing gum can be a cheap and easy therapeutic strategy to reduce the length of hospital stay, by diminishing the incidence and time of postoperative ileus (by the determination of the time patients take to tolerate oral intake, pass flatus and present bowel movements).

The investigators study hypothesis is stated as follows: Use of chewing gum in pediatric patients after gastrointestinal surgery reduces the risk of post-operative ileus by decreasing the time the patient takes to tolerate oral intake, pass flatus and present bowel movements.

Study Design

• Randomized Clinical Trial

• Prospective

• Experimental

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.

Investigators will register any adverse effect related with the use of chewing gum such as:

abdominal distension, abdominal pain, nausea, vomiting, ingestion of chewing gum, intestinal obstruction, or any other patient's complain while being in hospital. Medications used during treatment will also be reported with every patient included in the protocol.

There will be no intervention of any pharmaceutic industry or support of any chewing gum brand. Costs of the study will be covered by the principal investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric patients who underwent any type of gastrointestinal surgery.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ileus
• Post Operative Ileus

Intervention

Other:
• Chewing Gum
The use of chewing gum as a preventive measure for post-operative ileus

Locations

Country	Name	City	State
Mexico	Hospital San Jose Tec de Monterrey	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Vásquez W, Hernández 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time to First Flatus	The time between the end of surgery and the moment in which the patient passes first flatus	End of surgery to first flatus (from 1 to 3 days)	No
Secondary	Time to First Bowel Movement	The time between the end of surgery and the moment in which the patient presents first bowel movement.	End of surgery to first bowel motion (from 1 to 7 days)	No
Secondary	Time to Tolerate Feedings (Oral Intake)	The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.	End of surgery to oral intake tolerance (from 1 to 3 days)	No