STRATA: Surgical Treatment Using Robotic Approach in The Acute Abdomen

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPortsmouth Hospitals NHS Trust

About this trial

Robotic surgery in the UK is now widely used in elective procedures based on evidence that it can improve outcomes, with improved vision and precision for the surgeon resulting in better results and greater rates of minimally invasive surgery. Despite this, there remain some concerns about its use with some saying it adds cost with limited or no benefit to patients. Its application in the emergency setting has not been well studied. However, emergency patients are the sickest patients, and so stand to potentially gain the most from robotic surgery, if it is shown to be beneficial by enabling more precise surgery. The investigators aim to evaluate the impact of robotics in emergency general surgery, on outcomes, patients, and surgeons as well as the greater health system.

Given the need for modern health systems to reflect the needs and desires of their users, the investigators also aim to explore patient and surgeon preferences and priorities in emergency surgery with particular reference to surgical approach (open/laparoscopic/robotic).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patients who undergo emergency (non-elective) abdominal surgery

Patient scheduled to undergo either an open, robotic or laparoscopic approach to surgery

Willing and able to comply with study requirements

Must have access to an internet enabled device

Disqualifiers

<18 years of age

Inability to give informed consent

Minor procedures: Appendicectomy, abscess drainage

Inability to return or complete electronic questionnaires

Trial population

WP1. Any patients who undergo emergency (non-elective) general surgery via any surgical approach, robotic, open or laparoscopic as determined by the treating physician. WP2. Patients presenting to hospital with emergency general surgery conditions.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 2 trial groups
Group A: Patient Perspective Group
Group B: Emergency Surgery Group

Trial outcomes

Primary outcomes

1

Post-operative complications reported

Post-operative complications reported in health records and patient reported complications. Comparison of complications reported for robotics and non-robotic emergency surgery

Time frame
1 year

Secondary outcomes

1

Pre-operative questionnaire

Assessment of patient preferences and priorities in emergency surgery

Time frame
Pre-operative
2

Local Experienced Discomfort Questionnaire

Evaluation of surgeon related outcomes (ergonomics and discomfort) using the Local Experienced Discomfort Questionnaire

Time frame
Post-operation
3

QoL15 and EQ5D-3L questionnaires

Assessment of patient related clinical outcomes following robotic/laparoscopic emergency surgery i.e. QOL (pre-op and post-op) via QoR15 and EQ5D-3L questionnaires.

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

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