Gum Chewing, Honey, Ileostomy Closure, Postoperative Complications After Gastrointestinal Operations, Postoperative Recovery
Conditions
Keywords
ileostomy, reversal, stoma, closure, honey, gum, recovery, complications, ERAS, pilot, randomized control trial
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.
Interventions
DIETARY_SUPPLEMENTHoney
Group B patients were asked to eat one half tablespoon of natural honey every 4 hours
DIETARY_SUPPLEMENTgum chewing
Group A patients were asked to chew gum for 5 minutes every 4 hours
Sponsors
Mayo Hospital Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to pass flatus | 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 to bowel sounds | 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 to pass feces | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
| 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. | Defined as the time, in hours, of the postoperative hospital stay. |
| 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 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. |
| 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. | PONV was defined as the number of episodes of documented postoperative nausea/emesis or administration of a rescue antiemetic |
Countries
Pakistan
Outcome results
None listed