Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT07144969
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chewing Gum vs Honey in Postoperative Recovery After Ileostomy Reversal: A Study Comparing Their Effects on Bowel Function, Complications, and Hospital Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006722', 'term': 'Honey'}, {'id': 'D002638', 'term': 'Chewing Gum'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-20', 'size': 183992, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-08-20T02:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'description': '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'}, {'measure': '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.", 'description': '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'}, {'measure': '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.', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Time to full feeds', 'timeFrame': '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.', 'description': '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)'}, {'measure': 'Postoperative Pain', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': '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.', 'description': 'PONV was defined as the number of episodes of documented postoperative nausea/emesis or administration of a rescue antiemetic'}, {'measure': 'Length of postoperative stay/ Time to discharge', 'timeFrame': 'Assessed by calculating the time of hospital stay (in hours) between the Ileostomy reversal surgery up to 5 days (144 hours) postoperatively.', 'description': 'Defined as the time, in hours, of the postoperative hospital stay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ileostomy', 'reversal', 'stoma', 'closure', 'honey', 'gum', 'recovery', 'complications', 'ERAS', 'pilot', 'randomized control trial'], 'conditions': ['Ileostomy Closure', 'Gum Chewing', 'Honey', 'Postoperative Recovery', 'Postoperative Complications After Gastrointestinal Operations']}, 'referencesModule': {'references': [{'pmid': '34417055', 'type': 'BACKGROUND', 'citation': 'Behera BK, Misra S, Tripathy BB. 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Epub 2014 Oct 22.'}, {'pmid': '26092476', 'type': 'BACKGROUND', 'citation': 'Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: To evaluate the effects of chewing gum versus honey on postoperative recovery and complications in patients undergoing ileostomy reversal.\n\nMethods: 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.', 'detailedDescription': '"Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal - A Pilot Randomized Controlled Trial"\n\n1. Introduction\n\n Background\n\n 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.\n\n Rationale\n\n 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.\n2. Objective\n\n To compare the effects of chewing gum and honey on:\n\n Time to bowel sounds, flatus, feces Time to full feeds Postoperative ileus Intraabdominal infection Nausea and vomiting Postoperative hospital stay\n3. Methods\n\nStudy Design\n\nA prospective, single-blinded pilot randomized controlled trial was conducted at the West Surgical Ward, Mayo Hospital Lahore.\n\nParticipants\n\nSample 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\n\nInterventions\n\nGroup 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\n\nOutcomes\n\nPrimary: Time to bowel sounds, flatus, feces Secondary: Time to full feeds, PONV, pain score, discharge time, hospital stay, complications\n\nRandomization \\& Blinding\n\nRandomization was done using a lottery method. The study was single-blinded: participants were unaware of which group they were assigned to.\n\nData Collection\n\nStandardized protocols for auscultation, patient self-reporting, and case report documentation were used. All participants completed the trial without loss to follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients of age more than 18 years with an Ileostomy\n* Undergoing surgery involving reversal of an Ileostomy i.e., Loop Ileostomy, Double Barrel Ileostomy, Ileocolostomy or End Ileostomy\n* Time from fashioning of ileostomy to its reversal is of a duration greater than 1 month\n\nExclusion Criteria:\n\n* Patients with existing complications as mentioned above in the operative definition of postoperative complications\n* Patients with malignancy\n* Patients with inflammatory bowel disease\n* Patients who cannot communicate well\n* Patients who have difficulty chewing or swallowing\n* Patients who are prohibited from oral intake by the surgeon\n* Patients having undergone Ileostomy reversal more than 1 day before being included in the study'}, 'identificationModule': {'nctId': 'NCT07144969', 'briefTitle': 'Chewing Gum vs Honey in Postoperative Recovery After Ileostomy Reversal: A Study Comparing Their Effects on Bowel Function, Complications, and Hospital Stay', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Hospital Lahore'}, 'officialTitle': 'Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal', 'orgStudyIdInfo': {'id': 'IleostomyReversalHoneyvsGum'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - Intervention: Chewing gum every 4 hours', 'interventionNames': ['Dietary Supplement: gum chewing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - Intervention: Natural honey every 4 hours', 'interventionNames': ['Dietary Supplement: Honey']}], 'interventions': [{'name': 'Honey', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Group B patients were asked to eat one half tablespoon of natural honey every 4 hours', 'armGroupLabels': ['Group B - Intervention: Natural honey every 4 hours']}, {'name': 'gum chewing', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Group A patients were asked to chew gum for 5 minutes every 4 hours', 'armGroupLabels': ['Group A - Intervention: Chewing gum every 4 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Mayo Hospital, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Shahroze Wajid, Postgraduate Resident Surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Surgical Ward, Mayo Hospital, Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In light of patient doctor confidentiality, the individual patient data will not be disclosed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Hospital Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Shahroze Wajid', 'investigatorFullName': 'Shahroze Wajid', 'investigatorAffiliation': 'Mayo Hospital Lahore'}}}}