Paralytic Ileus Clinical Trial
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
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Indus Hospital | Aga Khan University |
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. — View Citation
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. — View Citation
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.
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.
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 — View Citation
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. — View Citation
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. Review. — View Citation
van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, Hulsewé 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | passage of stool | 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. | up to 24 hours post-operatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01131416 -
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
|
Phase 2/Phase 3 | |
Completed |
NCT03884244 -
Postoperative Chewing Gum and Gynecological Laparoscopic Surgery
|
N/A | |
Withdrawn |
NCT01389986 -
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04190173 -
Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus
|
Phase 3 | |
Completed |
NCT06113718 -
The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
|
N/A | |
Recruiting |
NCT03041675 -
Effects of Laser Acupuncture Therapy on Paralytic Ileus
|
N/A | |
Active, not recruiting |
NCT01607307 -
Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy
|
Phase 2 |