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The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery (GumGyn)

Primary Purpose

Postoperative Ileus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Chewing gum

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

18 years or older
Undergoing benign gynecologic surgery via an exploratory laparotomy
Capable of giving consent

Exclusion Criteria:

Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
Intubated or unconscious when leaving the OR
Bowel resection performed at the time of surgery
Active bowel disease (IBD, appendicitis, etc)
Gynecologic malignancy

Sites / Locations

Johns Hopkins Bayview
Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard postoperative care

Chewing gum arm

Arm Description

Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes

Outcomes

Primary Outcome Measures

Time to flatus

Secondary Outcome Measures

Postoperative ileus

Nausea, vomiting, abdominal distention two episodes of 100cc of emesis

time to discharge

time to toleration of diet

patient satisfaction

Full Information

NCT ID

NCT01579175

First Posted

April 13, 2012

Last Updated

March 13, 2013

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT01579175

Brief Title

The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

Acronym

GumGyn

Official Title

The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Ileus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard postoperative care

Arm Type

No Intervention

Arm Title

Chewing gum arm

Arm Type

Experimental

Arm Description

Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes

Intervention Type

Other

Intervention Name(s)

Chewing gum

Other Intervention Name(s)

Extra spearment sugar free gum

Intervention Description

Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.

Primary Outcome Measure Information:

Title

Time to flatus

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Postoperative ileus

Description

Nausea, vomiting, abdominal distention two episodes of 100cc of emesis

Time Frame

30 days

Title

time to discharge

Time Frame

30 days

Title

time to toleration of diet

Time Frame

30 days

Title

patient satisfaction

Time Frame

30 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older Undergoing benign gynecologic surgery via an exploratory laparotomy Capable of giving consent Exclusion Criteria: Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration Intubated or unconscious when leaving the OR Bowel resection performed at the time of surgery Active bowel disease (IBD, appendicitis, etc) Gynecologic malignancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine A Sewell, MD, MPH

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amelia M Jernigan, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Grace Chen, MD

Organizational Affiliation

Johns Hopkins Bayview

Official's Role

Study Director

Facility Information:

Facility Name

Johns Hopkins Bayview

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25147092

Citation

Jernigan AM, Chen CC, Sewell C. A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery. Int J Gynaecol Obstet. 2014 Dec;127(3):279-82. doi: 10.1016/j.ijgo.2014.06.008. Epub 2014 Jul 21.

Results Reference

derived

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The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

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