Health TrialsbyHealthPanel

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

ConditionNecrotising Enterocolitis Neonatal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neonate requiring emergency surgery to the abdomen

Parental consent given

Clinician agreement for randomisation

Disqualifiers

Absolute indication for surgery in particular location

No consent given

Trial design

Design model

Parallel

Treatments tested in this trial

  • IN theatre

    Procedure/Surgery

    Surgery will take place in the operating theatre

  • ON unit

    Procedure/Surgery

    Surgery will take place on the neonatal unit

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: In unit surgeryActive comparator 1 intervention
Group B: Theatre operatingActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: