Effect of Chewing Gum on Post-operative Ileus (GUMPI) (GUMPI)

February 16, 2022 updated by: Dr. Abdel Majid Sheikh Taha, American University of Beirut Medical Center

Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?

The purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. Post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries.

This study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. Patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. Both groups will be kept nothing per os (NPO) otherwise till the first bowel movement. The first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. The descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures.

This study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Asdghig Der-Boghossian, LD, MS
  • Phone Number: 5444 +961-1-350000
  • Email: ahd14@mail.aub.edu

Study Locations

  • Lebanon
      • Beirut, Lebanon, 11-236
        • Recruiting
        • American University of Beirut Medical Center
        • Contact:
          • Asdghig Der-Boghossian, LD, MS
          • Phone Number: 5463 +961-1-350000
          • Email: ahd14@mail.aub.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient 13 years of age or older
  • Patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation.

Exclusion Criteria:

  • Less than 13 years of age
  • Patients who have undergone with abdominal surgery within the last month
  • Patients with inability or problems with chewing and/or dysphagia
  • Patients who are expected to be kept intubated after surgery
  • Patients who are allergic to any chewing gum component

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chewing gum group
The patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement.
Dietary supplement: chewing gum
The patient will chew one piece (1.45g) of regular chewing gum starting morning of post-operative day 1 for 30 minutes each time, three times per day, till the first bowel movement.
NO_INTERVENTION: Control group
These patients will not be offered any food/beverage orally. Patients will be asked not to eat or chew anything till the first bowel movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first flatus time
Time Frame: post-operative hospital stay till discharge (up to 5 days)
time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery.
post-operative hospital stay till discharge (up to 5 days)
first defecation time
Time Frame: post-operative hospital stay till discharge (up to 5 days)
time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery.
post-operative hospital stay till discharge (up to 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOS
Time Frame: hospital stay (average of 5 days)
the length of hospital stay (throughout their hospital stay, average of 5 days)
hospital stay (average of 5 days)
Meal time
Time Frame: post-operative hospital stay till discharge (up to 5 days)
The time of first tolerable meal after surgery; monitored for first tolerable meal for up to 5 days after surgery.
post-operative hospital stay till discharge (up to 5 days)
post-operative ileus
Time Frame: post-operative hospital stay till discharge (up to 5 days)
presence of post-operative ileus; monitored for ileus for up to 5 days after surgery.
post-operative hospital stay till discharge (up to 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Abdel Majid Sheikh Taha, MD, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (ESTIMATE)

July 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUR.AMST.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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