Necrotizing EnterocolitisNCT04912453
Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
A study testing Primary anastomosis and Enterostomy in people with Necrotizing Enterocolitis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Primary anastomosis and Enterostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2021to 31 Dec 2025
- 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 Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates with confirmed NEC and require surgical intervention will be included
Who cannot join
- Neonates found to have NEC totalis and deemed unsalvageable;
- Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses;
- Neonates found to be extremely unstable cardiovascularly intra-operatively and can only withstand excision of gangrenous bowels, but will not allow anastomosis or stoma creation;
- Parents who do not agree to participate in the study
- Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery, University of Hong Kong
Hong Kong, 0000
Adrian Fung, MBBS, +85222554850, fungchiheng@gmail.com
About this study
Official title: A Randomised Controlled Trial to Compare Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. The advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years.
For NEC patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. Traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. However, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. Retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. It also has the advantage of avoiding a second operation for enterostomy closure. Nonetheless, prospective studies comparing the two approaches are lacking.
Read more
The proposed study will fill up the following knowledge gap on what the best surgical option for NEC at laparotomy is. The findings will help guide our practice for NEC patients in the future in order to provide them with the best possible and evidence-based care.
In this study, the investigators hypothesize that neonates with major NEC undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities.
Aim of the study is to compare the short term and medium term outcomes of NEC patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Primary anastomosis, Enterostomy
- Keywords
- Necrotizing Enterocolitis, Neonatal surgery, Primary anastomosis, Enterostomy
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary anastomosisProcedure or surgery
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis
EnterostomyProcedure or surgery
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy
| Study group | Role | What they receive |
|---|---|---|
| Primary anastomosis group | Experimental | Not described Receives: Procedure: Primary anastomosis |
| Enterostomy group | Experimental | Not described Receives: Procedure: Enterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation rate of the two surgical approaches
Measured: 6 months
Secondary outcomes (2)
Wound-related problems
Wound problems not requiring re-operations e.g. wound infection; stomal prolapse; incisional hernia
Measured: 6 months
Time to full enteral feeding
Time needed (in term of days) to achieve full enteral feeding (defined as 150ml/kg/day) and stoppage of parenteral feeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All neonates with confirmed NEC and require surgical intervention will be included. This is a local multi-centre study and neonates from the three centres which perform neonatal surgery will participate. At laparotomy, the diseased segment of intestine will be resected and the patients will then receive either primary anastomosis or enterostomy according to randomisation done pre-operatively.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth KY Wong, MD, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912453
- Sponsor's protocol ID
- NECHKTrial
- Status last verified
- May 2024
- First submitted
- 28 May 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
- ClinicalTrials.gov ID
- NCT04912453
- Acronym / sponsor ID
- NECHKTrial
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing Enterocolitis, Neonatal surgery, Primary anastomosis, Enterostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. The advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years.
For NEC patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. Traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. However, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. Retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. It also has the advantage of avoiding a second operation for enterostomy closure. Nonetheless, prospective studies comparing the two approaches are lacking.
The proposed study will fill up the following knowledge gap on what the best surgical option for NEC at laparotomy is. The findings will help guide our practice for NEC patients in the future in order to provide them with the best possible and evidence-based care.
In this study, the investigators hypothesize that neonates with major NEC undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities.
Aim of the study is to compare the short term and medium term outcomes of NEC patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All neonates with confirmed NEC and require surgical intervention will be included. This is a local multi-centre study and neonates from the three centres which perform neonatal surgery will participate. At laparotomy, the diseased segment of intestine will be resected and the patients will then receive either primary anastomosis or enterostomy according to randomisation done pre-operatively.
| Arm | Type | Receives |
|---|---|---|
| Primary anastomosis group | Experimental | Procedure: Primary anastomosis |
| Enterostomy group | Experimental | Procedure: Enterostomy |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates with confirmed NEC and require surgical intervention will be included
Key exclusion criteria (5 listed)
- Neonates found to have NEC totalis and deemed unsalvageable;
- Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses;
- Neonates found to be extremely unstable cardiovascularly intra-operatively and can only withstand excision of gangrenous bowels, but will not allow anastomosis or stoma creation;
- Parents who do not agree to participate in the study
- Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary anastomosisAt laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis | Procedure or surgery | Primary anastomosis group |
| EnterostomyAt laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy | Procedure or surgery | Enterostomy group |
Primary outcome
Re-operation rate of the two surgical approaches
Time frame: 6 months
2 secondary outcomes
Wound-related problems
Time frame: 6 months
Time to full enteral feeding
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth KY Wong, MD, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary anastomosis and Enterostomy in people with Necrotizing Enterocolitis, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Fung, MBBS (+85222554850, fungchiheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation rate of the two surgical approaches (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.