DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial.
BACKGROUND
Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.


METHODS
The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years.


CONCLUSIONS
Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation.


BACKGROUND
(Trial register number: NTR1478).
van de Wall
Bryan J M
BJ
Department of Surgery, Meander Medical Center Amersfoort, The Netherlands.
Draaisma
Werner A
WA
Consten
Esther C J
EC
van der Graaf
Yolanda
Y
Otten
Marten H
MH
de Wit
G Ardine
GA
van Stel
Henk F
HF
Gerhards
Michael F
MF
Wiezer
Marinus J
MJ
Cense
Huib A
HA
Stockmann
Hein B A C
HB
Leijtens
Jeroen W A
JW
Zimmerman
David D E
DD
Belgers
Eric
E
van Wagensveld
Bart A
BA
Sonneveld
Eric D J A
ED
Prins
Hubert A
HA
Coene
Peter P L O
PP
Karsten
Tom M
TM
Klaase
Joost M
JM
Statius Muller
Markwin G
MG
Crolla
Rogier M P H
RM
Broeders
Ivo A M J
IA
D000293:Adolescent; D000328:Adult; D000368:Aged; D004239:Diverticulitis, Colonic / Q000601:surgery* / Q000628:therapy*; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012008:Recurrence; D016896:Treatment Outcome; D057832:Watchful Waiting; D055815:Young Adult