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Ileostomy ClosureNCT07144969

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

A study testing Honey and gum chewing in people with Ileostomy Closure and Gum Chewing, run by Mayo Hospital Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ileostomy Closure, Gum Chewing, Honey
What is being tested?
Honey and gum chewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Feb 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Mayo Hospital, Lahore

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal

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.

Read the 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.

Being tested
Honey, gum chewing
Keywords
ileostomy, reversal, stoma, closure, honey, gum, recovery, complications, ERAS, pilot, randomized control trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HoneyDietary supplement

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

  • gum chewingDietary supplement

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

Study groups in NCT07144969
Study groupRoleWhat they receive
Group A - Intervention: Chewing gum every 4 hoursExperimentalNot described
Receives: Dietary Supplement: gum chewing
Group B - Intervention: Natural honey every 4 hoursActive comparatorNot described
Receives: Dietary Supplement: Honey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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.

  2. 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

    Measured: 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.

  3. 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

    Measured: 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)

  1. Time to full feeds

    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)

    Measured: 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.

  2. Postoperative Pain

    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.

    Measured: 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.

  3. Postoperative nausea and vomiting (PONV)

    PONV was defined as the number of episodes of documented postoperative nausea/emesis or administration of a rescue antiemetic

    Measured: 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.

  4. Length of postoperative stay/ Time to discharge

    Defined as the time, in hours, of the postoperative hospital stay.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start1 Feb 2024
  3. Primary completion31 Oct 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144969
Sponsor's protocol ID
IleostomyReversalHoneyvsGum
Status last verified
Aug 2025
First submitted
14 Jul 2025
Last updated
28 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In light of patient doctor confidentiality, the individual patient data will not be disclosed

Publications

  • Behera BK, Misra S, Tripathy BB. Systematic review and meta-analysis of safety and efficacy of early enteral nutrition as an isolated component of Enhanced Recovery After Surgery [ERAS] in children after bowel anastomosis surgery. J Pediatr Surg. 2022 Aug;57(8):1473-1479. doi: 10.1016/j.jpedsurg.2021.07.020. Epub 2021 Jul 28.

    PubMed 34417055

  • Gil-Vargas M, Saavedra-Pacheco MS, Coral-Garcia MA. Early Feeding versus Traditional Feeding in Children with Ileostomy Closure. J Indian Assoc Pediatr Surg. 2022 Mar-Apr;27(2):223-226. doi: 10.4103/jiaps.JIAPS_388_20. Epub 2022 Mar 1.

    PubMed 35937106

  • Peng Y, Xiao D, Xiao S, Yang L, Shi H, He Q, Xu H, Zhu X, Zhong W, Yu J. Early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A randomized multicenter controlled trial of an enhanced recovery after surgery (ERAS) component. J Pediatr Surg. 2021 Sep;56(9):1479-1484. doi: 10.1016/j.jpedsurg.2021.02.067. Epub 2021 Mar 18.

    PubMed 33838898

  • Hsu YC, Szu SY. Effects of Gum Chewing on Recovery From Postoperative Ileus: A Randomized Clinical Trail. J Nurs Res. 2022 Oct 1;30(5):e233. doi: 10.1097/jnr.0000000000000510.

    PubMed 35951432

  • Park SH, Choi MS. Meta-Analysis of the Effect of Gum Chewing After Gynecologic Surgery. J Obstet Gynecol Neonatal Nurs. 2018 May;47(3):362-370. doi: 10.1016/j.jogn.2018.01.011. Epub 2018 Mar 3.

    PubMed 29505755

  • Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

    PubMed 30426190

  • Bhatti S, Malik YJ, Changazi SH, Rahman UA, Malik AA, Butt UI, Umar M, Farooka MW, Ayyaz M. Role of Chewing Gum in Reducing Postoperative Ileus after Reversal of Ileostomy: A Randomized Controlled Trial. World J Surg. 2021 Apr;45(4):1066-1070. doi: 10.1007/s00268-020-05897-1. Epub 2021 Jan 5.

    PubMed 33403448

  • Lin Z, Li Y, Wu J, Zheng H, Yang C. Nomogram for prediction of prolonged postoperative ileus after colorectal resection. BMC Cancer. 2022 Dec 6;22(1):1273. doi: 10.1186/s12885-022-10377-x.

    PubMed 36474177

  • Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.

    PubMed 35588252

  • Atkins CS, Tubog TD, Schaffer SK. Chewing Gum After Radical Cystectomy With Urinary Diversion for Recovery of Intestinal Function: A Systematic Review and Meta-Analysis. J Perianesth Nurs. 2022 Aug;37(4):467-473. doi: 10.1016/j.jopan.2021.10.003. Epub 2022 Mar 8.

    PubMed 35272926

  • Luo J, Xia M, Zhang C. The Effects of Chewing Gum on Reducing Anxiety and Stress: A Meta-Analysis of Randomized Controlled Trials. J Healthc Eng. 2022 Jan 31;2022:8606693. doi: 10.1155/2022/8606693. eCollection 2022.

    PubMed 35140905

  • de Gaay Fortman DPE, Kroon HM, Bedrikovetski S, Fitzsimmons TR, Dudi-Venkata NN, Sammour T. A snapshot of intraoperative conditions to predict prolonged postoperative ileus after colorectal surgery. ANZ J Surg. 2022 Sep;92(9):2199-2206. doi: 10.1111/ans.17784. Epub 2022 May 17.

    PubMed 35579059

  • Li K, Wang D, Zhang X, Yang J, Chen X. Efficacy of early enteral nutrition versus total parenteral nutrition for patients with gastric cancer complicated with diabetes mellitus: A systematic review and meta-analysis. Nutr Diet. 2022 Feb;79(1):129-139. doi: 10.1111/1747-0080.12721.

    PubMed 35233912

  • Akbulut S, Dogan Z, Baskiran A, Elbe H, Turkoz Y. Effect of a honey and arginine-glutamine-hydroxymethylbutyrate mixture on the healing of colon anastomosis in rats immunosuppressed with tacrolimus. Biotech Histochem. 2019 Oct;94(7):514-521. doi: 10.1080/10520295.2019.1601257. Epub 2019 Apr 15.

    PubMed 30983411

  • Negahi AR, Hosseinpour P, Vaziri M, Vaseghi H, Darvish P, Bouzari B, Mousavie SH. Comparison of Honey versus Polylactide Anti-Adhesion Barrier on Peritoneal Adhesion and Healing of Colon Anastomosis in Rabbits. Open Access Maced J Med Sci. 2019 May 25;7(10):1597-1601. doi: 10.3889/oamjms.2019.284. eCollection 2019 May 31.

    PubMed 31210807

Questions about this trial

What is this clinical trial studying?

A study testing Honey and gum chewing in people with Ileostomy Closure and Gum Chewing, run by Mayo Hospital Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to pass flatus (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144969, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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