Chewing Gum vs Honey in Postoperative Recovery After Ileostomy Reversal: A Study Comparing Their Effects on Bowel Function, Complications, and Hospital Stay

NCT07144969 | Completed

• 1 other identifier: IleostomyReversalHoneyvsGum
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy Closure; Gum Chewing; Honey; Postoperative Recovery; Postoperative Complications After Gastrointestinal Operations

Keywords

ileostomy; reversal; stoma; closure; honey; gum; recovery; complications; ERAS; pilot; randomized control trial

Outcome Measures

Primary Outcomes (3)

• Time to pass flatus

  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

  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.

• Time to bowel sounds

  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

  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.

• Time to pass feces

  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

  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.

Secondary Outcomes (4)

• Time to full feeds

  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.

• Postoperative Pain

  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 nausea and vomiting (PONV)

  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.

• Length of postoperative stay/ Time to discharge

  Assessed by calculating the time of hospital stay (in hours) between the Ileostomy reversal surgery up to 5 days (144 hours) postoperatively.

Study Arms (2)

Group A - Intervention: Chewing gum every 4 hours

EXPERIMENTAL

Dietary Supplement: gum chewing

Group B - Intervention: Natural honey every 4 hours

ACTIVE COMPARATOR

Dietary Supplement: Honey

Interventions

Honey DIETARY_SUPPLEMENT

Group B patients were asked to eat one half tablespoon of natural honey every 4 hours

Group B - Intervention: Natural honey every 4 hours

gum chewing DIETARY_SUPPLEMENT

Group A patients were asked to chew gum for 5 minutes every 4 hours

Group A - Intervention: Chewing gum every 4 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

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MeSH Terms

Interventions

Honey; Chewing Gum

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy

Study Officials

• Shahroze Wajid, Postgraduate Resident Surgery

  West Surgical Ward, Mayo Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Shahroze Wajid

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 28, 2025
• Study Start: February 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)