Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT07144969
Brief Summary:
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.
Detailed Description:
"Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal - A Pilot Randomized Controlled Trial"
1. Introduction
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.
2. Objective
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
3. Methods
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.
Study:
NCT07144969
Study Brief:
Protocol Section:
NCT07144969