The Swedish Crohn Trial: A Prematurely Terminated Randomized Controlled Trial of Thiopurines or Open Surgery for Primary Treatment of Ileocaecal Crohn's Disease.
OBJECTIVE
The importance of efficient and safe treatment of Crohn's disease is highlighted by its chronicity. Both medical and surgical treatments have shown good results in the symptomatic control of limited ileocaecal Crohn's disease. The aim of this study was to compare medical treatment with surgical treatment of ileocaecal Crohn's disease.


METHODS
Thirty-six patients from seven hospitals with primary ileocaecal Crohn's disease were randomized to either medical or surgical treatment. The medical treatment was induction of remission with budesonide and thereafter maintenance treatment with azathioprine. The surgical treatment was open ileocaecal resection. Crohn's disease activity index over time, expressed as area under the curve at 1, 3 and 5 years, was the primary endpoint. Subjective health measured with the 36-item Short Form Survey Instrument (SF36) and a visual analogue scale (VAS) were secondary endpoints.


RESULTS
There were no differences between the treatment groups in Crohn's disease activity index over time. General health, measured as SF36 score, was higher in patients receiving surgical treatment than in those receiving medical treatment at 1 year, but there was no corresponding difference in VAS. Due to the slow inclusion rate and changes in clinical practice, the study was t=erminated prematurely.


CONCLUSIONS
The study ended up being underpowered and should be interpreted with caution, but there was no clinically significant difference between the two treatment arms. Further studies are needed to address this important clinical question.
Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery, County Council of Östergötland, Linköping, Sweden, Department of Surgery, Höglandssjukhuset, Eksjö, Sweden.
Linda
L
Gerdin
Department of Gastroenterology Sahlgrenska University Hospital/Östra, Gothenburg, Sweden.
Anders S
AS
Eriksson
Department of Surgery, Northern Hospital Zeeland, Copenhagen, Denmark.
Gunnar
G
Olaison
Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery, County Council of Östergötland, Linköping, Sweden.
Rune
R
Sjödahl
Department of Gastroenterology, County Council of Östergötland, Linköping, Sweden.
Magnus
M
Ström
Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery, County Council of Östergötland, Linköping, Sweden.
Johan D
JD
Söderholm
Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery, County Council of Östergötland, Linköping, Sweden, par.myrelid@liu.se.
Pär
P
Myrelid
D000328:Adult; D000367:Age Factors; D000714:Anastomosis, Surgical / Q000379:methods; D019540:Area Under Curve; D001379:Azathioprine / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002432:Cecum / Q000473:pathology / Q000601:surgery; D003082:Colectomy / Q000379:methods*; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007082:Ileum / Q000473:pathology / Q000601:surgery; D007813:Laparotomy / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D018709:Statistics, Nonparametric; D013548:Sweden; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
D019819:Budesonide; D001379:Azathioprine
Surgery; clinical trials; quality of life; socio-economical and psychological endpoints