LaCeS2

• Research type

  Research Study

• Full title

  A multicentre, randomised controlled trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting (LaCeS2 Trial)

• IRAS ID

  291081

• Contact name

  Deena Harji

• Contact email

  d.harji@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  4 years, 5 months, 30 days

• Research summary

  Emergency general surgery is one of the most common reasons for admission to hospital. A wide range of problems can lead to emergency admission, and diseases that affect the large bowel (e.g. diverticular disease and cancer) make up a third of diseases that present as an emergency.

  There are two different types of operation which can be used in surgery; keyhole surgery which involves several small cuts to allow surgical instruments to access the inside of the body, and open surgery (where a bigger cut is made). Currently, keyhole surgery is used in planned (elective) surgery involving the large bowel, but in the emergency setting surgeons opt for open surgery more often. Surgeons think that using keyhole surgery in the emergency setting may result in shorter recovery time, reduced pain and shorter length of hospital stay compared with open surgery, however we are not sure if this is definitely the case, as the current evidence is not strong enough to draw any firm conclusions.

  LaCeS2 will run in NHS hospitals within acute general surgery services. Patients requiring emergency surgery on the large bowel will be invited to participate in the trial in which half will be treated with open surgery and half with keyhole surgery. Treatment will not be chosen by the patient or their doctor but through a process called randomisation. This trial will help determine the effectiveness and cost-effectiveness of keyhole surgery in the emergency setting. Participants will be followed up for 12 months after their operation. We will also collect information about why patients choose to take part in the trial or not and ask recruiting staff about the trial and recruitment processes. We will also investigate whether using routine health data could be a reliable way of collecting surgical clinical trial data in future.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  21/NW/0303

• Date of REC Opinion

  22 Dec 2021

• REC opinion

  Further Information Favourable Opinion