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The Effect of Chewing Gum on Nausea, Vomiting and Bowel Function After Colorectal Surgery

Primary Purpose

Postsurgical Ileus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
gum chewing
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postsurgical Ileus focused on measuring postsurgical ileus, chewing gum, colorectal surgery

Eligibility Criteria

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

Inclusion Criteria: Being over 18 years old, To have applied for elective colorectal surgery, Having undergone laparoscopic colorectal surgery, Not having a nasogastric insertion, Not having a vision-hearing problem, ECOG performance score to be between 0-2, Exclusion Criteria: Performing emergency surgical intervention, Open colorectal surgery Need for intensive care after surgery, Stoma has been opened

Sites / Locations

  • Tarsus Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

gum chewing

control group

Arm Description

All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. For the patients in the experimental group, sugar-free xylitol gum containing 1.2-1.37 grams of xylitol per piece, available in the market, will be used. Participants in the experimental group will start chewing gum on the first postoperative day and will be allowed to chew a single piece of gum 3 times a day at 9:00, 14:00 and 19:00, respectively, for 15 minutes. The gum will be given to the participants regularly by a researcher until the first reported flatulence.

All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. The control group will receive only standard care.

Outcomes

Primary Outcome Measures

prevention of postoperative ileus
The first postoperative gas removal time and the first postoperative stool removal time will be questioned by the researcher. There is no standard scale for this.
Prevention of nausea-vomiting.
Nausea and Vomiting Evaluation Form. In our study, PONV status will be evaluated as "Yes/No" at 0, 2, 4, 8, 12 and 24 hours using the Nausea and Vomiting Evaluation Form.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2023
Last Updated
September 1, 2023
Sponsor
Cukurova University
Collaborators
Tarsus University
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1. Study Identification

Unique Protocol Identification Number
NCT06029790
Brief Title
The Effect of Chewing Gum on Nausea, Vomiting and Bowel Function After Colorectal Surgery
Official Title
The Effect of Chewing Gum on Nausea, Vomiting and Bowel Functions After Colorectal Surgery: A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
Collaborators
Tarsus University

4. Oversight

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

5. Study Description

Brief Summary
False feeding refers to promoting gastrointestinal peristalsis by seeing, smelling, chewing, and tasting food, not getting food into the gastrointestinal tract. Postoperative sham feeding uses gum to promote the healing of gastrointestinal peristalsis. Although not fully understood, the physiological theory underlying gum chewing (fake feeding) to stimulate peristalsis and reduce postoperative intestinal recovery time is that the oral and chewing stimulation provided by chewing gum stimulates a neurohumoral reflex that increases gastrointestinal fluid secretion. This increases gastrointestinal motility. In addition, oral stimulation and chewing can stimulate the vagus nerve, which is also involved in promoting peristalsis. Finally, none of the existing theories adequately explain the effect of chewing/gum chewing on reducing postoperative inflammation in the gut, which may result in a reduced incidence of postoperative infection. In previous studies, physiological changes associated with gum appear to promote normal gastrointestinal function and subsequent postoperative/anesthetic recovery. Although many studies have been conducted to examine the effectiveness of chewing gum in patients undergoing colorectal resection, the results have been inconsistent. This can be attributed to differences in intestinal injuries affecting bowel function, differences in time under anesthesia and differences in anesthetics or pain control agents used for pain control affecting bowel function, and recovery time of peristalsis. Given the many factors known to affect postoperative ileus, chewing gum as an intervention remains a safe, accessible, and inexpensive option that remains to be explored.
Detailed Description
False feeding refers to promoting gastrointestinal peristalsis by seeing, smelling, chewing and tasting food, not getting food into the gastrointestinal tract. Postoperative sham feeding uses gum to promote healing of gastrointestinal peristalsis. Although not fully understood, the physiological theory underlying gum chewing (fake feeding) to stimulate peristalsis and reduce postoperative intestinal recovery time is that the oral and chewing stimulation provided by chewing gum stimulates a neurohumoral reflex that increases gastrointestinal fluid secretion. This increases gastrointestinal motility. In addition, oral stimulation and chewing can stimulate the vagus nerve, which is also involved in promoting peristalsis. Finally, none of the existing theories adequately explain the effect of chewing/gum chewing on reducing postoperative inflammation in the gut, which may result in a reduced incidence of postoperative infection. Previous studies have shown that physiological changes associated with gum support normal gastrointestinal function and subsequent postoperative/anesthetic recovery. Some studies have shown that chewing gum after colorectal resection reduces postoperative flatulence and defecation time. showed that it reduces the risk of postoperative ileus. In contrast, some studies in patients undergoing open abdominal surgery or laparoscopy for various types of colorectal resection have shown no effect of chewing gum on postoperative first flatulence and time to defecation, has no significant effect in reducing the average hospital stay and has no significant effect in preventing postoperative nausea, vomiting, or bloating. One possible reason for the inconsistent results of sham feeding using chewing gum to reduce the incidence of postoperative ileus may be differences in underlying colorectal cancer types and heterogeneity between surgical and postoperative care methods. Although many studies have been conducted to examine the effectiveness of chewing gum in patients undergoing colorectal resection, the results have been inconsistent. This can be attributed to differences in intestinal injuries affecting bowel function, differences in time under anesthesia differences in anesthetics or pain control agents used for pain control affecting bowel function, and recovery time of peristalsis. Given the many factors known to affect postoperative ileus, chewing gum as an intervention remains a safe, accessible, and inexpensive option that remains to be explored. This study will provide empirical evidence that contributes to a body of literature supporting gum administration for affecting postoperative nausea, flatulence, and stool output in a well-defined sample. Many interventions and strategies have been used to manage postoperative ileus, such as prokinetic agents and epidural anesthesia. However, these methods have limited efficacy and still have a relatively high incidence of postoperative ileus. Alternatively, chewing gum promotes gastrointestinal peristalsis in post-surgery patients without the adverse effects associated with early feeding. However, results in studies investigating the effect of chewing gum on postoperative recovery of gastrointestinal function after colorectal surgery are conflicting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Ileus
Keywords
postsurgical ileus, chewing gum, colorectal surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was planned as a prospective, single-blind, parallel-group, randomized controlled study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gum chewing
Arm Type
Experimental
Arm Description
All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. For the patients in the experimental group, sugar-free xylitol gum containing 1.2-1.37 grams of xylitol per piece, available in the market, will be used. Participants in the experimental group will start chewing gum on the first postoperative day and will be allowed to chew a single piece of gum 3 times a day at 9:00, 14:00 and 19:00, respectively, for 15 minutes. The gum will be given to the participants regularly by a researcher until the first reported flatulence.
Arm Title
control group
Arm Type
No Intervention
Arm Description
All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. The control group will receive only standard care.
Intervention Type
Other
Intervention Name(s)
gum chewing
Intervention Description
For the patients in the experimental group, sugar-free xylitol gum containing 1.2-1.37 grams of xylitol per piece, available in the market, will be used. Participants in the experimental group will start chewing gum on the first postoperative day and will be allowed to chew a single piece of gum 3 times a day at 9:00, 14:00 and 19:00, respectively, for 15 minutes. The gum will be given to the participants regularly by a researcher until the first reported flatulence.
Primary Outcome Measure Information:
Title
prevention of postoperative ileus
Description
The first postoperative gas removal time and the first postoperative stool removal time will be questioned by the researcher. There is no standard scale for this.
Time Frame
72 hours
Title
Prevention of nausea-vomiting.
Description
Nausea and Vomiting Evaluation Form. In our study, PONV status will be evaluated as "Yes/No" at 0, 2, 4, 8, 12 and 24 hours using the Nausea and Vomiting Evaluation Form.
Time Frame
72 saat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being over 18 years old, To have applied for elective colorectal surgery, Having undergone laparoscopic colorectal surgery, Not having a nasogastric insertion, Not having a vision-hearing problem, ECOG performance score to be between 0-2, Exclusion Criteria: Performing emergency surgical intervention, Open colorectal surgery Need for intensive care after surgery, Stoma has been opened
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DERYA GEZER
Phone
+905076990081
Email
deryasahhin@hotmail.com
Facility Information:
Facility Name
Tarsus Universty
City
Mersin
State/Province
Tarsus
ZIP/Postal Code
33400
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results on the effects of chewing gum on nausea, vomiting and bowel functions after colorectal surgery will be shared. However, personal information will not be shared.
Citations:
PubMed Identifier
25524125
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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Results Reference
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Links:
URL
https://doi.org/10.1016/j.cnre.2017.02.001
Description
Chewing gum for postoperative ileus after colorectal surgery: A systematic review of overlapping meta-analyses

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The Effect of Chewing Gum on Nausea, Vomiting and Bowel Function After Colorectal Surgery

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