CompletedNot Applicable

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

Pakistan60 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to pass flatus

Timeframe: 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

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT07144969

SponsorMayo Hospital Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Ileostomy Closure trials