title: DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial.
abstract: 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).
authors.affiliation: Department of Surgery, Meander Medical Center Amersfoort, The Netherlands.
authors.forename: Bryan J M
authors.initials: BJ
authors.lastname: van de Wall
authors.forename: Werner A
authors.initials: WA
authors.lastname: Draaisma
authors.forename: Esther C J
authors.initials: EC
authors.lastname: Consten
authors.forename: Yolanda
authors.initials: Y
authors.lastname: van der Graaf
authors.forename: Marten H
authors.initials: MH
authors.lastname: Otten
authors.forename: G Ardine
authors.initials: GA
authors.lastname: de Wit
authors.forename: Henk F
authors.initials: HF
authors.lastname: van Stel
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gerhards
authors.forename: Marinus J
authors.initials: MJ
authors.lastname: Wiezer
authors.forename: Huib A
authors.initials: HA
authors.lastname: Cense
authors.forename: Hein B A C
authors.initials: HB
authors.lastname: Stockmann
authors.forename: Jeroen W A
authors.initials: JW
authors.lastname: Leijtens
authors.forename: David D E
authors.initials: DD
authors.lastname: Zimmerman
authors.forename: Eric
authors.initials: E
authors.lastname: Belgers
authors.forename: Bart A
authors.initials: BA
authors.lastname: van Wagensveld
authors.forename: Eric D J A
authors.initials: ED
authors.lastname: Sonneveld
authors.forename: Hubert A
authors.initials: HA
authors.lastname: Prins
authors.forename: Peter P L O
authors.initials: PP
authors.lastname: Coene
authors.forename: Tom M
authors.initials: TM
authors.lastname: Karsten
authors.forename: Joost M
authors.initials: JM
authors.lastname: Klaase
authors.forename: Markwin G
authors.initials: MG
authors.lastname: Statius Muller
authors.forename: Rogier M P H
authors.initials: RM
authors.lastname: Crolla
authors.forename: Ivo A M J
authors.initials: IA
authors.lastname: Broeders
mesh_terms: 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