Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population

NCT04489875 | Unknown DMC

• 1 other identifier: 456-784-9
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative ileus (POI) is defined as a temporary cessation of bowel movement after a surgical procedure. Surgical procedures not only include abdominal or colorectal procedures but non-abdominal procedures as well. Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance. These patients tend to have more pain scores and dissatisfaction with the surgical management and team. The mechanism behind this condition is caused by a decrease in vagal parasympathetic stimulation. To break/prevent this mechanism, here comes the "sham feeding" (gum-chewing) effect where an increase in chewing and saliva enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion even in non-gastro or colorectal surgeries. This effect is studied thoroughly in gastric, colorectal, and gynecological procedures. There is scarcity about its effect following orthopedic procedures specifically hip arthroplasty. The objective of this study is to assess the effect of adding gum-chewing to the conventional postoperative feeding regimen on restoring postoperative bowel function and length of stay in hospital of patients undergoing elective hip arthroplasty. Interventions: Behavioral intervention (Chewing gum) will be started the morning after surgery when the patient is fully awake and allowed to start taking an oral diet (which usually starts within 6-10 hours after surgery). In addition to the conventional postoperative feeding schedule, the patient will be given the gum to chew for at least 15 minutes each time, 3 times/day before the usual time of the meal, until the first flatus. The control group will have a conventional feeding schedule without chewing gum being added to their meals. Hypothesis: The investigators hypothesize that there is an association between gum chewing and the relief from postoperative ileus in hip arthroplasty patients. Study Design: Single-center, open-label, parallel design, superiority randomized-controlled trial with 2 treatment arms. The primary outcome will be the time interval in hours from the end of surgery until the passage of flatus, which is reported subjectively by the patient. The secondary outcome will be the time interval in hours from the end of surgery until the passage of stool. The other secondary outcome will be the postoperative hospital stay in days (surgery to discharge).

Conditions

Paralytic Ileus

Keywords

Hip Arthroplasty; Chewing gum; Sham Feeding

Outcome Measures

Primary Outcomes (1)

• Passage of Flatus

  the time interval in hours from the end of surgery until the first passage of flatus, which is reported subjectively by the patient. Patients will be instructed to make note of the time when flatus is passed for the first time after surgery.

  up to 12 hours post-operatively

Secondary Outcomes (1)

• passage of stool

  up to 24 hours post-operatively

Study Arms (2)

Chewing gum

EXPERIMENTAL

the patients in this arm will receive the post-operative oral feeding along with chewing gum which they'll be required to chew for at least 15 minutes before their meal 3 times a day

Behavioral: Chewing Gum

No chewing gum

NO INTERVENTION

The patients in this arm will only receive the post-operative oral feeding

Interventions

Chewing Gum BEHAVIORAL

The intervention would be chewing gum. The patients in the intervention arm would be asked to chew gum for 15 minutes before meals thrice a day.

Chewing gum

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 50-70 years
• Undergoing elective primary hip arthroplasty surgery
• ASA grade I, II, and III
• The patients undergoing general anesthesia with/without neuraxial anesthesia

You may not qualify if:

• Patients refusing to consent
• Patients already having an established nasogastric (NG) tube/gastrostomy feeding, or unsafe/unable to swallow due to any neurological condition
• Patients with documented bowel disease other than peptic ulcers
• History of chronic constipation more than 3 days before surgery
• Inability to chew gum due to dental issues
• traumatic and revision cases of arthroplasty
• adjuvant surgical procedures (abdominal, thoracic, etc.) besides the primary arthroplasty procedure will also be excluded from the study.

Sponsors & Collaborators

• Indus Hospital and Health Network: lead
• Aga Khan University: collaborator

Related Publications (9)

• Kalyanwat as, jakhar m, jain s. Postoperative ileus: a study on the role of chewing gum to reduce its duration. Saudi surgical journal. 2018 jul 1;6(3):85.

  BACKGROUND

• Begum s, shahzad n, murtaza g, rehman zu, hasnain zafar gc. Of post-operative ileus after colorectal surgeries: a randomized control trial. Clinics of sugery. 2018; 1 (1): 1-5. Age (years). 2018;55(13.5):51-9.

  BACKGROUND

• Matros E, Rocha F, Zinner M, Wang J, Ashley S, Breen E, Soybel D, Shoji B, Burgess A, Bleday R, Kuntz R, Whang E. Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial. J Am Coll Surg. 2006 May;202(5):773-8. doi: 10.1016/j.jamcollsurg.2006.02.009.

  PMID: 16648017 BACKGROUND

• 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.

  PMID: 25524125 BACKGROUND

• Atkinson C, Penfold CM, Ness AR, Longman RJ, Thomas SJ, Hollingworth W, Kandiyali R, Leary SD, Lewis SJ. Randomized clinical trial of postoperative chewing gum versus standard care after colorectal resection. Br J Surg. 2016 Jul;103(8):962-70. doi: 10.1002/bjs.10194. Epub 2016 May 5.

  PMID: 27146793 BACKGROUND

• Karmali S, Jenkins N, Sciusco A, John J, Haddad F, Ackland GL; POM-X Study Investigators. Randomized controlled trial of vagal modulation by sham feeding in elective non-gastrointestinal (orthopaedic) surgery. Br J Anaesth. 2015 Nov;115(5):727-35. doi: 10.1093/bja/aev283. Epub 2015 Aug 30.

  PMID: 26323293 RESULT

• Asao T, Kuwano H, Nakamura J, Morinaga N, Hirayama I, Ide M. Gum chewing enhances early recovery from postoperative ileus after laparoscopic colectomy. J Am Coll Surg. 2002 Jul;195(1):30-2. doi: 10.1016/s1072-7515(02)01179-1.

  PMID: 12113542 RESULT

• Noble EJ, Harris R, Hosie KB, Thomas S, Lewis SJ. Gum chewing reduces postoperative ileus? A systematic review and meta-analysis. Int J Surg. 2009 Apr;7(2):100-5. doi: 10.1016/j.ijsu.2009.01.006. Epub 2009 Jan 31.

  PMID: 19261555 RESULT

• Hasan O, Mazhar L, Jiwani A, Begum D, Lakdawala R, Noordin S. Gum Chewing, Added to Conventional Feeding, Reduces Risk of Post-Operative Ileus after Elective Hip and Knee Arthroplasty Procedures in Elderly Population: A Protocol for a Parallel Design, Open-Label, Randomized Controlled Trial. Int J Surg Protoc. 2021 Aug 9;25(1):165-170. doi: 10.29337/ijsp.158. eCollection 2021.

  PMID: 34435165 DERIVED

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Obada Hassan, MSc. Epibio

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahryar Noordin, MBBS

CONTACT

+922134864350; shahryar.noordin@aku.edu

Dilshad Begum

CONTACT

+922134862303; dilshad.begum@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Biostatistician

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: July 28, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share