The Effect of Gum Chewing on Postoperative Ileus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Wake Forest School of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00879294
First received: April 9, 2009
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.


Condition Intervention Phase
Perforated Appendicitis
Device: Motion sickness wristband
Dietary Supplement: Chewing Gum
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Gum Chewing on Postoperative Ileus

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Time to resolution of post-operative ileus. [ Time Frame: 1-14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1 Wristband
Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.
Device: Motion sickness wristband
No drugs are involved.
Experimental: Chewing Gum
Patients will be randomized to use chewing gum after surgery.
Dietary Supplement: Chewing Gum
Patients will be asked to chew gum for 20 minutes, four times daily.
No Intervention: Control
Usual post-operative care.

Detailed Description:

After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any child who has undergone appendectomy for perforated appendicitis

Exclusion Criteria:

  • age less than or equal to 5 years
  • unable to chew gum safely
  • interval appendectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879294

Contacts
Contact: Thomas Pranikoff, MD 336-716-0546 tpraniko@wfubmc.edu

Locations
United States, North Carolina
Brenner Children's Hospital Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Thomas Pranikoff, MD    336-716-0546    tpraniko@wfubmc.edu   
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Thomas Pranikoff, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Thomas Pranikoff, M.D., Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT00879294     History of Changes
Other Study ID Numbers: CR1_IRB00005677
Study First Received: April 9, 2009
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Perforated appendicitis
Ruptured appendicitis
Acute appendicitis with perforation

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014