Mayo Hospital, Lahore
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT07144969
Title: Comparison of the effect of chewing gum and honey on postoperative recovery and complications in ileostomy reversal - a pilot randomized controlled trial Background: Ileostomy reversal is associated with postoperative complications such as ileus, delayed gastrointestinal function recovery (GIFR), and infections. Chewing gum (sham feeding) and honey have been proposed as cost-effective interventions to enhance recovery, but their comparative efficacy remains underexplored.
Objective: To evaluate the effects of chewing gum versus honey on postoperative recovery and complications in patients undergoing ileostomy reversal.
Methods: A prospective single-blinded pilot randomized controlled trial is to be conducted at Mayo Hospital, Lahore, involving 30 patients (15 per group). Group A received chewing gum, while Group B received honey, starting 24 hours postoperatively. Primary outcomes included time to bowel sounds, flatus, and feces. Secondary outcomes were time to full feeds, intraabdominal infections, postoperative ileus, nausea/vomiting, and length of hospital stay. Data significance was set at p < 0.05.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
"Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal - A Pilot Randomized Controlled Trial"
Background
Ileostomy reversal is a standard procedure following temporary diversion surgeries, yet it's frequently complicated by issues such as ileus, delayed gastrointestinal function recovery (GIFR), infections, and longer hospital stays. Enhanced Recovery After Surgery (ERAS) protocols have emphasized early feeding and noninvasive stimulatory interventions like sham feeding (e.g., chewing gum), aiming to improve outcomes by accelerating return of bowel function. Honey, long known for its medicinal and antimicrobial properties, has also shown promise in enhancing gastrointestinal health and wound healing. However, its use postoperatively in gastrointestinal surgery, particularly ileostomy reversal, has not been well studied.
Rationale
This study addresses the research gap concerning the comparative effects of chewing gum and honey in enhancing postoperative recovery following ileostomy reversal. It aims to evaluate their efficacy in improving outcomes and reducing complications, using a pilot randomized controlled trial design.
To compare the effects of chewing gum and honey on:
Time to bowel sounds, flatus, feces Time to full feeds Postoperative ileus Intraabdominal infection Nausea and vomiting Postoperative hospital stay
Study Design
A prospective, single-blinded pilot randomized controlled trial was conducted at the West Surgical Ward, Mayo Hospital Lahore.
Participants
Sample size: 30 patients (15 per group) Inclusion: Adults (>18 years) undergoing ileostomy reversal after >1 month of stoma creation Exclusion: Malignancy, Irritable bowel disease (IBD), inability to chew/swallow, preexisting complications
Interventions
Group A (Gum): Chewed gum for 5 minutes every 4 hours, starting 24 hours postop Group B (Honey): Consumed ½ tablespoon honey every 4 hours, starting 24 hours postop
Outcomes
Primary: Time to bowel sounds, flatus, feces Secondary: Time to full feeds, PONV, pain score, discharge time, hospital stay, complications
Randomization & Blinding
Randomization was done using a lottery method. The study was single-blinded: participants were unaware of which group they were assigned to.
Data Collection
Standardized protocols for auscultation, patient self-reporting, and case report documentation were used. All participants completed the trial without loss to follow up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group B patients were asked to eat one half tablespoon of natural honey every 4 hours
Group A patients were asked to chew gum for 5 minutes every 4 hours
Time frame: Assessed by asking the patient if they have passed flatus every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgery and the documented passage of the first objectively confirmed flatus by auscultation or direct observation
Time frame: Assessed by ausculating the patients' abdomen to listen to the presence or absence of bowel sounds every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgical closure and the first audible auscultation of non-continuous, high-pitched bowel sounds originating from the reconnected intestine, documented by a trained healthcare professional using a stethoscope placed over the lower quadrants of the abdomen
Time frame: Assessed by asking the patient if they have passed stool every 8 hours starting from 24 hours after the Ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgery and the documented first independent bowel movement, excluding any stool manually evacuated or stimulated by laxatives
Time frame: Assessed by asking the patient if they have taken full feeds every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the surgery and the first point at which the patient tolerates and consumes a regular, unrestricted diet without experiencing any significant postoperative gastrointestinal complications (e.g., nausea, vomiting, abdominal pain, ileus) for a predetermined timeframe (i.e., 24 hours)
Time frame: Assessed by asking the patient about their abdominal pain using a Visual Analog score from 0 to 10 every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Postoperative pain in stoma reversal surgery was defined as the subjective pain intensity experienced by the patient at rest or during movement, assessed using the Visual Analog Scale (VAS). The VAS consists of a 10 cm horizontal line anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10), with patients marking the point on the line that best represented their pain intensity.
Time frame: Assessed by asking the patient about the number of vomiting episodes or nausea they had every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
PONV was defined as the number of episodes of documented postoperative nausea/emesis or administration of a rescue antiemetic
Time frame: Assessed by calculating the time of hospital stay (in hours) between the Ileostomy reversal surgery up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, of the postoperative hospital stay.
Mayo Hospital Lahore
Other
Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal
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