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| Name | Class |
|---|---|
| Khyber Teaching Hospital | OTHER |
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Postoperative ileus (POI) is a frequent complication after abdominal surgery, leading to delayed gastrointestinal motility, prolonged hospital stay, and increased patient discomfort. Chewing gum, as a form of sham feeding, has been proposed to stimulate gut motility through vagal stimulation and increased gastrointestinal secretions. This randomized controlled trial aims to assess the effect of chewing gum on early recovery of gastrointestinal motility in patients undergoing open gastrointestinal surgery.
This prospective randomized controlled trial will evaluate whether chewing gum reduces the time to return of bowel function after gastrointestinal surgery. Ninety-six adult patients undergoing open gastrointestinal surgery will be randomly allocated into intervention and control groups using block randomization. The intervention group will receive glucose-containing chewing gum starting six hours postoperatively. Outcomes measured include time to first bowel sounds, passage of flatus, and defecation. Statistical analysis will assess differences between groups to determine the efficacy of chewing gum in preventing postoperative ileus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing Gum Intervention Group | Experimental | Participants will receive glucose/carbohydrate-containing chewing gum starting 6 hours after surgery. Patients will chew gum for 15 minutes, three times daily, for 48 hours or until first passage of flatus or stool, in addition to standard postoperative care. |
|
| Standard Care Control Group | No Intervention | Participants will receive standard postoperative care without chewing gum intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewing Gum | Behavioral | Participants will chew glucose/carbohydrate-containing chewing gum for 15 minutes, three times daily, starting 6 hours after surgery and continuing for 48 hours or until the first passage of flatus or stool, in addition to standard postoperative care. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Passage of Flatus | Time interval (in hours) from the end of surgery to the first postoperative passage of flatus, assessed by patient self-report and clinical evaluation. | Within 48 hours postoperatively |
| Time to First Defecation | Time interval (in hours) from the end of surgery to the first postoperative bowel movement (defecation), assessed by patient self-report and clinical evaluation. | Within 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ali Raza, MBBS | Contact | +923452479895 | dralicenna022@gmail.com | |
| Dr Munir Ahmed, FCPS | Contact | +923339493884 | drmunir29@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Ali Raza, MBBS | Khyber Teaching Hospital | Principal Investigator |
| Dr Munir Ahmed, FCPS | Khyber Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber Teaching Hospital | Recruiting | Peshawar | KPK | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34676664 | Background | Wells CI, Milne TGE, Seo SHB, Chapman SJ, Vather R, Bissett IP, O'Grady G. Post-operative ileus: definitions, mechanisms and controversies. ANZ J Surg. 2022 Jan;92(1-2):62-68. doi: 10.1111/ans.17297. Epub 2021 Oct 22. | |
| 26550107 | Background | Ge W, Chen G, Ding YT. Effect of chewing gum on the postoperative recovery of gastrointestinal function. Int J Clin Exp Med. 2015 Aug 15;8(8):11936-42. eCollection 2015. |
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De-identified individual participant data (IPD) related to study outcomes, baseline characteristics, and statistical analyses will be shared with qualified researchers upon reasonable request, after publication of the primary study results. Data will be shared to promote transparency and facilitate further research while ensuring participant confidentiality.
Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access to de-identified IPD will be granted to researchers who provide a methodologically sound research proposal, with approval from the principal investigator and institutional ethical review board. A data use agreement will be required prior to data sharing.
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Participants will be randomly assigned to two parallel groups. An intervention group receiving chewing gum and a control group receiving standard postoperative care without chewing gum.
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This is an open-label study. Neither participants nor investigators are blinded due to the nature of the intervention.
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| 35951432 | Background | 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. |
| 40072350 | Background | Lew SL, Cheng LJ, Yap SY, Liaw YQ, Park J, Lau ST. Effect of chewing gum on clinical outcomes and postoperative recovery in adult patients after gastrointestinal surgery: an umbrella review. Int J Surg. 2025 May 1;111(5):3481-3493. doi: 10.1097/JS9.0000000000002332. |
| 32103455 | Background | Roslan F, Kushairi A, Cappuyns L, Daliya P, Adiamah A. The Impact of Sham Feeding with Chewing Gum on Postoperative Ileus Following Colorectal Surgery: a Meta-Analysis of Randomised Controlled Trials. J Gastrointest Surg. 2020 Nov;24(11):2643-2653. doi: 10.1007/s11605-019-04507-3. Epub 2020 Feb 26. |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |