Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04489875|
Recruitment Status : Not yet recruiting
First Posted : July 28, 2020
Last Update Posted : July 30, 2020
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.
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.
The investigators hypothesize that there is an association between gum chewing and the relief from postoperative ileus in hip arthroplasty patients.
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Shahryar Noordin, MBBS||+922134864350 ext email@example.com|
|Contact: Dilshad Begum||+922134862303 ext firstname.lastname@example.org|
|Principal Investigator:||Obada Hassan, MSc. Epibio||Aga Khan University|