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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Jamie Hall
+44 (0)114 222 2963
jamie.hall@sheffield.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - A randomised controlled trial to assess whether the amount of mesentery removed, or the type of bowel join used during surgery for Crohn's disease, can affect the chances of getting further disease

A randomised controlled trial to assess whether the amount of mesentery removed, or the type of bowel join used during surgery for Crohn's disease, can affect the chances of getting further disease

Medical Conditions

Crohn’s disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Crohn’s is a disease that makes the bowel red, swollen and painful. It is a lifelong disease. Some people get few flare-ups. Other people may have really bad and long-lasting symptoms. There is no cure for Crohn’s, but drugs can treat the symptoms. If the drugs do not work surgery may be needed. Whilst surgery can also stop symptoms for a long time, the disease can return. Further drugs and even further surgery may be needed. Many surgeons feel that the way the bowel and the tissue containing the blood and other vessels supplying the bowel (the mesentery) is removed and the way the healthy bowel ends are re-joined can affect the success of surgery. Two changes to the way surgeons operate have been proposed. One involves taking out more of the mesentery and the other involves doing another type of bowel join. This is known as the Kono-S join. They are safe but researchers need to test that they are better than the usual method in stopping further disease. In this study the researchers will ask people if they would let them carry out one or both of these methods. They will then see if they have reduced the chances of further disease 1 year later. The type of surgery a person has will be decided by chance.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

02 May 2022 31 Oct 2024

If a patient is eligible and happy to be part of the study, they will be asked to sign a consent form. They will then complete three questionnaires and be asked some questions about their medical history. On the day of the surgery the surgeon will confirm the patient is eligible and the patient will be allocated to one of the study groups by chance (randomised). The surgeon will then perform the type of surgery as decided by the randomisation. Six weeks after surgery patients will be asked to complete the questionnaires again during their visit to the hospital (this visit is part of standard care for all patients having this kind of surgery, even if they are not in the trial). After 6 to 12 months patients normally have a colonoscopy as part of the follow-up after the surgery. At this time the participants will be asked to complete the three questionnaires again. The researchers will also look at the participants' medical notes for up to 3 years after the surgery to see if Crohn's disease has come back. At some sites participants will have additional blood and tissue samples taken during their surgery and colonoscopy. These will be analysed to help the researchers understand what might be causing Crohn's disease.


Patients who are undergoing surgery (ileocaecal resection) for Crohn's disease where the bowel is re-joined (anastomosis).

You can take part if:



You may not be able to take part if:


Participant exclusion criteria as of 10/11/2023: 1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation2. Patients undergoing stoma formation proximal to the anastomosis3. Patients who have a contraindication to subsequent colonoscopy4. Patients unable to give full informed consent5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care)6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery



Previous participant exclusion criteria:1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation2. Patients undergoing stoma formation3. Patients who have a contraindication to subsequent colonoscopy4. Patients unable to give full informed consent5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care)6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Central Middlesex Hospital
    Acton Lane
    London
    NW10 7NS
  • Churchill Hospital
    Old Road Headington
    Oxford
    OX3 7LE
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Queen Elizabeth University Hospital
    1345 Govan Road
    Glasgow
    G51 4TF
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Northern General Hospital
    Northern General Hospital NHS Trust C Floor, Huntsmnan Building Herries Road
    Sheffield
    S5 7AU
  • Kettering General Hospital
    Rothwell Road
    Kettering
    NN16 8UZ
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Russells Hall Hospital
    Pensnett Road
    Dudley
    DY1 2HQ
  • Norfolk & Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Bristol Royal Infirmary
    Marlborough Street
    Bristol
    BS2 8HW
  • Manchester Royal Infirmary
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • University Hospital (coventry)
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Royal Cornwall Hospital (treliske)
    Treliske
    Truro
    TR1 3LJ
  • Royal Devon and Exeter Hospital
    Royal Devon & Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Wythenshawe Hospital
    Southmoor Road Wythenshawe
    Manchester
    M23 9LT
  • Chelsea & Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • Solihull Hospital
    Lode Lane
    Solihull
    B91 2JL
  • Bolton Royal Hospital
    Minerva Road Farnworth
    Bolton
    BL4 0JR
  • Royal Albert Edward Infirmary
    Wigan Lane
    Wigan
    WN1 2NN
  • Guys Hospital
    Great Maze Pond
    London
    SE1 9RT
  • Huddersfield Royal Infirmary
    Acre Street
    Huddersfield
    HD3 3EA
  • Sandwell District General Hospital
    Lyndon
    West Bromwich
    B71 4HJ
  • Queen's Hospital Burton
    Belvedere Road
    Burton on Trent
    DE13 0RB

Taking part in this study will mean no additional appointments at the hospital compared to the number of appointments patients receive normally. The risks associated with the different surgery types are not thought to be any different to usual surgery for Crohn’s disease, and the surgeon will discuss this further with patients as part of standard surgery pre-assessment. Several studies have shown that all the surgical procedures are safe. Complications that are associated with Crohn’s surgery will have been discussed with the patient and include: leak of the join in the bowel, bleeding, bowel blockage (ileus), wound infection, urinary infection, heart events, clots in the leg or lungs, chest infection, hernia, and damage to other parts of the abdomen. Additionally, very rarely patients may have a reaction to the anaesthetic.

Dr Jamie Hall
+44 (0)114 222 2963
jamie.hall@sheffield.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR131988.




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Read full details for Trial ID: ISRCTN16900055

Or CPMS 52048

Last updated 13 November 2024

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