Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202601716524491 Date of Registration: 06/01/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Timing of Nasogastric Tube Removal and Its Impact on Postoperative Bowel Function Recovery and Feeding Following Major Bowel Surgery in Children
Official scientific title A Prospective Randomized Controlled Trial on the Impact of Early versus Delayed Nasogastric Tube Removal on Postoperative Bowel Function Recovery and Feeding in Children Undergoing Major Bowel Surgery
Brief summary describing the background and objectives of the trial Delayed return of bowel function is a common challenge following major bowel surgery in children and often prolongs hospitalization, delays feeding, and increases the risk of postoperative morbidity. Nasogastric tubes (NGTs) are routinely used to decompress the gastrointestinal tract, but there is no universally accepted guideline on the optimal timing for their removal in paediatric surgical patients. Early removal may enhance recovery by reducing discomfort and promoting earlier feeding, while delayed removal may minimize the risk of vomiting and aspiration. Evidence in children, however, remains limited. This study aims to determine whether early removal of the nasogastric tube after major bowel surgery improves postoperative bowel function recovery and feeding outcomes compared with delayed removal. Specifically, the trial evaluates the impact of early versus delayed NGT removal on the timing of return of bowel sounds, passage of flatus and stool, initiation of oral feeding, achievement of full feeding, and overall postoperative recovery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NGT-Paeds Trial
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 06/04/2020
Actual trial start date 06/04/2020
Anticipated date of last follow up 05/04/2022
Actual Last follow-up date 05/04/2022
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early Removal of NG tube 24 hours Participants in Group 1 had their nasogastric tube removed 24 hours after the completion of surgery. After removal, patients were closely monitored for return of bowel function, including the presence of bowel sounds, passage of flatus, and passage of stool. Oral feeding was initiated once gastrointestinal recovery markers were observed and was gradually advanced to full feeding as tolerated. All other aspects of postoperative care, including intravenous fluids, antibiotics, analgesics, and vital signs monitoring, were standardized and identical to the other study group. 51
Control Group Delayed NG tube removal Variable- until the patient passed flatus Participants in Group 2 had their nasogastric tube retained postoperatively until they passed flatus and/or stool, indicating the return of bowel function. Once these gastrointestinal recovery markers were observed, the NGT was removed. After removal, patients were closely monitored for tolerance of oral feeding, gradual advancement to full feeding, and other postoperative recovery parameters. All other aspects of postoperative care—including intravenous fluids, antibiotics, analgesics, and vital signs monitoring—were standardized and identical to the early NGT removal group. 51 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children aged 0–18 years undergoing major bowel surgery. 2. Caregivers/parents provide written informed consent for participation. 3. Patients are clinically stable after preoperative optimization. 4. Patients able to comply with postoperative monitoring and follow-up requirements. 1. Caregivers or patients who did not give assent/consent. 2. Patients who had gastric or duodenal surgery. 3. Patients who had non-bowel surgeries. 4. Unconscious patients. 5. Patients with deranged electrolyte results. Infant: 1 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 9 Month(s) 46 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/03/2019 NAUTH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nnewi Onitsha Road, Nnewi Nnewi 435109 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcome: Time to return of bowel sounds Definition: Measured in hours from the end of surgery (closure of the abdomen) to the first auscultated bowel sounds. Assessment Method: Patients were examined twice daily (8 am and 8 pm), and abdominal auscultation was performed to identify the presence or absence of bowel sounds. The exact time of first bowel sounds was recorded for each patient. Time Frame: From end of surgery until first bowel sounds postoperatively. 8am and 8pm daily
Secondary Outcome Time to passage of flatus 8am and 8pm daily
Secondary Outcome Time to passage of stool measured in hours from the end of surgery until the first passage of stool.
Secondary Outcome Time to initiation of oral feeding measured in hours from the end of surgery until the patient starts oral feeding.
Secondary Outcome Time to achievement of full feeding measured in hours from the end of surgery until the patient tolerates full-scale oral feeding.
Secondary Outcome Number and frequency of postoperative vomiting episodes recorded by caregivers and verified during twice-daily clinical review.
Secondary Outcome Length of hospital stay measured in days from surgery to discharge meeting clinical criteria.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Onitsha Road, Nnewi Nnewi 435109 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ezidiegwu Ugochukwu Nnamdi Azikiwe University Teaching Hospital Nnewi 435109 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ezidiegwu Ugochukwu Nnamdi Azikiwe University Teaching Hospital Nnewi 435109 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ugochukwu Ezidiegwu Ugostanleymd@gmail.com +2348032741118 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Paediatrics Surgeon
Role Name Email Phone Street address
Public Enquiries Chuka Ugwunne chuksug@yahoo.co.uk +2347030970899 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Paediatrics Surgeon
Role Name Email Phone Street address
Scientific Enquiries Victor Modekwe victormodekwe@yahoo.com +2348036083266 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Paediatrics Surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data to be collected include demographic variables (age, sex), clinical diagnosis, type of surgery performed, timing of nasogastric tube removal, postoperative outcomes (time to first bowel sounds, time to passage of flatus and stool, episodes of vomiting, time to initiation and achievement of full oral feeding), postoperative complications, length of hospital stay, and discharge status. Study Protocol Individual Participant Data will be made available beginning 6 months after publication of the study results and will remain accessible for a period of 5 years thereafter. Access to the Individual Participant Data will be granted to qualified researchers who submit a methodologically sound proposal outlining the intended use of the data. Requests must include a data-use agreement ensuring confidentiality and ethical use. Approval will be determined by the Principal Investigator and, when required, the institutional ethics committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/12/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/12/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 10/12/2025 Name of source was initially written as "self", but now, the replaced with the ACTUAL name of the source who is the principal investigator Self, Nnamdi Azikiwe University Teaching Hospital, Nnewi, 435109, Nigeria, Self Funded, Ezidiegwu Ugochukwu , Nnamdi Azikiwe University Teaching Hospital, Nnewi, 435109, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 19/12/2025 I am uploading the Result summary now No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 19/12/2025 Uploaded the summary results 39674_27962_1045.pdf