- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06029790
The Effect of Chewing Gum on Nausea, Vomiting and Bowel Function After Colorectal Surgery
The Effect of Chewing Gum on Nausea, Vomiting and Bowel Functions After Colorectal Surgery: A Randomized Clinical Study
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: DERYA GEZER
- Phone Number: +905076990081
- Email: deryasahhin@hotmail.com
Study Locations
-
-
-
Adana, Turkey
- Recruiting
- Cukurova University
-
Contact:
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gum chewing
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. |
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.
|
No Intervention: control group
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevention of postoperative ileus
Time Frame: 72 hours
|
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.
|
72 hours
|
Prevention of nausea-vomiting.
Time Frame: 72 saat
|
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.
|
72 saat
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, Hulsewe KW, de Jonge WJ, Buurman WA, Luyer MD. Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. Br J Surg. 2015 Feb;102(3):202-11. doi: 10.1002/bjs.9691. Epub 2014 Dec 18.
- Kobayashi T, Masaki T, Kogawa K, Matsuoka H, Sugiyama M. Efficacy of Gum Chewing on Bowel Movement After Open Colectomy for Left-Sided Colorectal Cancer: A Randomized Clinical Trial. Dis Colon Rectum. 2015 Nov;58(11):1058-63. doi: 10.1097/DCR.0000000000000452.
- Yang P, Long WJ, Wei L. Chewing Xylitol Gum could Accelerate Bowel motility Recovery after Elective Open Proctectomy for Rectal Cancer. Rev Invest Clin. 2018;70(1):53-58. doi: 10.24875/RIC.18002428.
- Liu Q, Jiang H, Xu D, Jin J. Effect of gum chewing on ameliorating ileus following colorectal surgery: A meta-analysis of 18 randomized controlled trials. Int J Surg. 2017 Nov;47:107-115. doi: 10.1016/j.ijsu.2017.07.107. Epub 2017 Sep 1.
- Hsu YC, Szu SY. Effects of Gum Chewing on Recovery From Postoperative Ileus: A Randomized Clinical Trail. J Nurs Res. 2022 Oct 1;30(5):e233. doi: 10.1097/jnr.0000000000000510.
- Lee JT, Hsieh MH, Cheng PJ, Lin JR. The Role of Xylitol Gum Chewing in Restoring Postoperative Bowel Activity After Cesarean Section. Biol Res Nurs. 2016 Mar;18(2):167-72. doi: 10.1177/1099800415592966. Epub 2015 Jul 7.
- Forrester DA, Doyle-Munoz J, McTigue T, D'Andrea S, Natale-Ryan A. The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial. J Wound Ostomy Continence Nurs. 2014 May-Jun;41(3):227-32. doi: 10.1097/WON.0000000000000019.
- Suh SY, Leblanc TW, Shelby RA, Samsa GP, Abernethy AP. Longitudinal patient-reported performance status assessment in the cancer clinic is feasible and prognostic. J Oncol Pract. 2011 Nov;7(6):374-81. doi: 10.1200/JOP.2011.000434.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC (NINDS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postsurgical Ileus
-
Assiut UniversityRecruitingPostoperative IleusEgypt
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Ileus | Gynecologic Disease | Paralytic IleusTurkey
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenRecruitingPostoperative IleusBelgium
-
West China HospitalCompletedPostoperative IleusChina
-
Hadassah Medical OrganizationCompleted
-
li xiongUnknown
-
Jinling Hospital, ChinaCompletedPostoperative IleusChina
-
Services Hospital, LahoreCompletedPostoperative IleusPakistan
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenCompletedPostoperative IleusBelgium
-
Gabriele Baldini, MD, MSc, Assistant ProfessorCompleted
Clinical Trials on gum chewing
-
Denver Nephrologists, P.C.CM&D Pharma LimitedCompletedChronic Kidney Disease | HyperphosphatemiaUnited States
-
Medical University of ViennaCompletedGestational Diabetes Mellitus in PregnancyAustria
-
Ahmed Salah Ahmed Abd ElgalilCompletedEndotracheal Intubation | Randomized Controlled Trial | Sore Throat | Gum ChewingEgypt
-
Instituto Tecnologico y de Estudios Superiores...Completed
-
University Hospital, LimogesActive, not recruiting
-
Istanbul Demiroglu Bilim UniversityCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Ileus | Gynecologic Disease | Paralytic IleusTurkey
-
State University of New York - Upstate Medical...Terminated
-
Michael Bau MortensenUnknownPancreatic Cancer | Cancer EsophagusDenmark
-
Chiang Mai UniversityCompletedParalytic IleusThailand