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

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ClinicalTrials.gov Identifier: NCT04489875
Recruitment Status : Not yet recruiting
First Posted : July 28, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
Aga Khan University
Information provided by (Responsible Party):
Ahsun Jiwani, Indus Hospital and Health Network

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).


Condition or disease Intervention/treatment Phase
Paralytic Ileus Behavioral: Chewing Gum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population: A Parallel Design, Open-Label, Randomized Controlled Trial
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: Chewing gum
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
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.

No Intervention: No chewing gum
The patients in this arm will only receive the post-operative oral feeding



Primary Outcome Measures :
  1. Passage of Flatus [ Time Frame: up to 12 hours post-operatively ]
    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.


Secondary Outcome Measures :
  1. passage of stool [ Time Frame: up to 24 hours post-operatively ]
    the time interval in hours from the end of surgery until the first passage of stool, which is reported subjectively by the patient. Patients and the bedside nurse will be instructed to make note of the time when the stool is passed for the first time after surgery.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489875


Contacts
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Contact: Shahryar Noordin, MBBS +922134864350 ext 4350 shahryar.noordin@aku.edu
Contact: Dilshad Begum +922134862303 ext 2303 dilshad.begum@aku.edu

Sponsors and Collaborators
Indus Hospital and Health Network
Aga Khan University
Investigators
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Principal Investigator: Obada Hassan, MSc. Epibio Aga Khan University
Publications of Results:
Other Publications:
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Responsible Party: Ahsun Jiwani, Junior Biostatistician, Indus Hospital and Health Network
ClinicalTrials.gov Identifier: NCT04489875    
Other Study ID Numbers: 456-784-9
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahsun Jiwani, Indus Hospital and Health Network:
Hip Arthroplasty
Chewing gum
Sham Feeding
Additional relevant MeSH terms:
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Ileus
Intestinal Pseudo-Obstruction
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases