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The Effect of Gum Chewing on Postoperative Ileus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Thomas Pranikoff, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00879294
First received: April 9, 2009
Last updated: July 17, 2017
Last verified: July 2017
  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
Perforated Appendicitis Device: Motion sickness wristband Dietary Supplement: Chewing Gum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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 Thomas Pranikoff, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Time to resolution of post-operative ileus. [ Time Frame: 1-14 days ]

Enrollment: 0
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879294

Locations
United States, North Carolina
Brenner Children's Hospital
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Thomas Pranikoff, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Thomas Pranikoff, Professor, Surgery Pediatrics, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00879294     History of Changes
Other Study ID Numbers: CR1_IRB00005677
Study First Received: April 9, 2009
Last Updated: July 17, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Thomas Pranikoff, Wake Forest University Health Sciences:
Perforated appendicitis
Ruptured appendicitis
Acute appendicitis with perforation

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 23, 2017