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Not yet recruitingNCT07754435NeoLapUpdated Aug 10, 2026

Neonatal Laparotomy - A Trial Investigating the Impact of Location of Surgery

An interventional study of IN theatre and ON unit in Necrotising Enterocolitis Neonatal, sponsored by Guy's and St Thomas' NHS Foundation Trust. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Sex
All
01

Study summary

This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.

Outcome will include physiological markers of instability, wound infection, death and others. There will also be a concurrent qualitative workstream exploring the impact of different practices on the wider clinical environment.

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Conditions studied

  • Necrotising Enterocolitis Neonatal

Keywords

  • Neonatal
  • Surgery
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In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 15 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neonate requiring emergency surgery to the abdomen
  • Parental consent given
  • Clinician agreement for randomisation

Exclusion criteria

Exclusion Criteria:

  • Absolute indication for surgery in particular location
  • No consent given
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    In unit surgery

    Babies will have their surgery performed on the neonatal unit without transfer to a theatre

    Procedure: ON unit

  • Active comparator
    Theatre operating

    Babies will be transferred to the operating theatre for surgery

    Procedure: IN theatre

Interventions

  • ProcedureIN theatre

    Surgery will take place in the operating theatre

  • ProcedureON unit

    Surgery will take place on the neonatal unit

06

What researchers measure

Primary outcomes

  1. Death

    Survival to discharge

    Time frame: Until discharge from hospital from primary episode, around 3-4 months

Secondary outcomes

  1. Physiological parameters

    As a pilot study, many different physiological parameters as markers of clinical stability will be collected and assessed for their suitability in a definitive study

    Time frame: During the course of the admission, including the immediate peri-operative period and subsequent recovery phase. Four weeks from surgery

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07754435
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 10, 2026

Study contacts

Iain E Yardley, FRCS BM MPH
Contact
i.yardley@nhs.net
00447901777079

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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