Chewing Gum vs Honey in Postoperative Recovery After Ileostomy Reversal: A Study Comparing Their Effects on Bowel Function, Complications, and Hospital Stay
NCT ID: NCT07144969
Last Updated: 2025-08-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-01
Study Completion Date
2024-11-30
Brief Summary
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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.
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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Detailed Description
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"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.
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.
Conditions
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Ileostomy Closure
Gum Chewing
Honey
Postoperative Recovery
Postoperative Complications After Gastrointestinal Operations
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This was a prospective, single-blinded, parallel-group randomized controlled pilot trial with a 1:1 allocation ratio conducted at Mayo Hospital, Lahore. Thirty patients undergoing ileostomy reversal were randomized into two groups using a lottery method: Group A received chewing gum, and Group B received natural honey, both starting 24 hours postoperatively. Group A chewed gum for 5 minutes every 4 hours, while Group B consumed half a tablespoon of honey every 4 hours. Primary outcomes (time to pass flatus, stools and bowel sounds) and secondary outcomes (time to full feeds, Postoperative ileus, Intraabdominal infection, Nausea and vomiting, Postoperative hospital stay) were recorded every 8 hours.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Selection bias were addressed by randomly assigning the participants to the groups. Performance bias cannot be eliminated due to different surgeons performing the ileostomy reversal surgery. Detection bias were addressed by keeping the participants unaware of what group they are assigned to and because of the objective nature of the outcome variables. There was still some detection bias in some respects involving the subjective opinion of the participants e.g. pain score. Intention-to-treat analysis were done to address attrition bias.
Study Groups
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Group A - Intervention: Chewing gum every 4 hours
Group Type
EXPERIMENTAL
gum chewing
Intervention Type
DIETARY_SUPPLEMENT
Group A patients were asked to chew gum for 5 minutes every 4 hours
Group B - Intervention: Natural honey every 4 hours
Group Type
ACTIVE_COMPARATOR
Honey
Intervention Type
DIETARY_SUPPLEMENT
Group B patients were asked to eat one half tablespoon of natural honey every 4 hours
Interventions
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Honey
Group B patients were asked to eat one half tablespoon of natural honey every 4 hours
Intervention Type
DIETARY_SUPPLEMENT
gum chewing
Group A patients were asked to chew gum for 5 minutes every 4 hours
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* All patients of age more than 18 years with an Ileostomy
* Undergoing surgery involving reversal of an Ileostomy i.e., Loop Ileostomy, Double Barrel Ileostomy, Ileocolostomy or End Ileostomy
* Time from fashioning of ileostomy to its reversal is of a duration greater than 1 month
* Undergoing surgery involving reversal of an Ileostomy i.e., Loop Ileostomy, Double Barrel Ileostomy, Ileocolostomy or End Ileostomy
* Time from fashioning of ileostomy to its reversal is of a duration greater than 1 month
Exclusion Criteria
* Patients with existing complications as mentioned above in the operative definition of postoperative complications
* Patients with malignancy
* Patients with inflammatory bowel disease
* Patients who cannot communicate well
* Patients who have difficulty chewing or swallowing
* Patients who are prohibited from oral intake by the surgeon
* Patients having undergone Ileostomy reversal more than 1 day before being included in the study
* Patients with malignancy
* Patients with inflammatory bowel disease
* Patients who cannot communicate well
* Patients who have difficulty chewing or swallowing
* Patients who are prohibited from oral intake by the surgeon
* Patients having undergone Ileostomy reversal more than 1 day before being included in the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Mayo Hospital Lahore
OTHER
Sponsor Role
lead
Responsible Party
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Shahroze Wajid
Dr. Shahroze Wajid
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shahroze Wajid, Postgraduate Resident Surgery
Role: PRINCIPAL_INVESTIGATOR
West Surgical Ward, Mayo Hospital, Lahore
Locations
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Mayo Hospital, Lahore
Lahore, Punjab Province, Pakistan
Site Status
Countries
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Pakistan
References
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IleostomyReversalHoneyvsGum
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
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COMPLETED
NA
Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery
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COMPLETED
NA
Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty
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UNKNOWN
EARLY_PHASE1
Influence of Early-feeding on Digestive Function of Patients After Esophageal Recontraction Surgery
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UNKNOWN
NA
Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial
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RECRUITING
NA