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

Primary Purpose

Ileus

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
chewing gum
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ileus focused on measuring chewing gum, prevention

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • American University of Beirut Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chewing gum group

Control group

Arm Description

The patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement.

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.

Outcomes

Primary Outcome Measures

first flatus time
time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery.
first defecation time
time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery.

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2016
Last Updated
February 16, 2022
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02847364
Brief Title
Effect of Chewing Gum on Post-operative Ileus (GUMPI)
Acronym
GUMPI
Official Title
Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
chewing gum, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chewing gum group
Arm Type
Experimental
Arm Description
The patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
chewing gum
Intervention Description
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.
Primary Outcome Measure Information:
Title
first flatus time
Description
time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery.
Time Frame
post-operative hospital stay till discharge (up to 5 days)
Title
first defecation time
Description
time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery.
Time Frame
post-operative hospital stay till discharge (up to 5 days)
Secondary Outcome Measure Information:
Title
LOS
Description
the length of hospital stay (throughout their hospital stay, average of 5 days)
Time Frame
hospital stay (average of 5 days)
Title
Meal time
Description
The time of first tolerable meal after surgery; monitored for first tolerable meal for up to 5 days after surgery.
Time Frame
post-operative hospital stay till discharge (up to 5 days)
Title
post-operative ileus
Description
presence of post-operative ileus; monitored for ileus for up to 5 days after surgery.
Time Frame
post-operative hospital stay till discharge (up to 5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asdghig Der-Boghossian, LD, MS
Phone
+961-1-350000
Ext
5444
Email
ahd14@mail.aub.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdel Majid Sheikh Taha, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
11-236
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asdghig Der-Boghossian, LD, MS
Phone
+961-1-350000
Ext
5463
Email
ahd14@mail.aub.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27927468
Citation
Jennings JK, Doyle JS, Gilbert SR, Conklin MJ, Khoury JG. The Use of Chewing Gum Postoperatively in Pediatric Scoliosis Patients Facilitates an Earlier Return to Normal Bowel Function. Spine Deform. 2015 May;3(3):263-266. doi: 10.1016/j.jspd.2014.12.001. Epub 2015 Apr 23.
Results Reference
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PubMed Identifier
25914904
Citation
Short V, Herbert G, Perry R, Atkinson C, Ness AR, Penfold C, Thomas S, Andersen HK, Lewis SJ. Chewing gum for postoperative recovery of gastrointestinal function. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD006506. doi: 10.1002/14651858.CD006506.pub3.
Results Reference
background
PubMed Identifier
24629205
Citation
Zhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14.
Results Reference
background
PubMed Identifier
24184650
Citation
Fineberg SJ, Nandyala SV, Kurd MF, Marquez-Lara A, Noureldin M, Sankaranarayanan S, Patel AA, Oglesby M, Singh K. Incidence and risk factors for postoperative ileus following anterior, posterior, and circumferential lumbar fusion. Spine J. 2014 Aug 1;14(8):1680-5. doi: 10.1016/j.spinee.2013.10.015. Epub 2013 Oct 31.
Results Reference
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Effect of Chewing Gum on Post-operative Ileus (GUMPI)

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