Open Access Highly Accessed Study protocol

DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

Bryan JM van de Wall1, Werner A Draaisma1, Esther CJ Consten1*, Yolanda van der Graaf2, Marten H Otten3, G Ardine de Wit2, Henk F van Stel2, Michael F Gerhards4, Marinus J Wiezer5, Huib A Cense6, Hein BAC Stockmann7, Jeroen WA Leijtens8, David DE Zimmerman9, Eric Belgers10, Bart A van Wagensveld11, Eric DJA Sonneveld12, Hubert A Prins13, Peter PLO Coene14, Tom M Karsten15, Joost M Klaase16, Markwin G Statius Muller17, Rogier MPH Crolla18, Ivo AMJ Broeders1* and the Dutch Diverticular Disease (3D) Collaborative Study Group

Author Affiliations

1 Department of Surgery, Meander Medical Center Amersfoort, Utrechtseweg 160, 3818 ES Amersfoort, The Netherlands

2 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands

3 Department of Gastroenterology, Meander Medical Center Amersfoort, Utrechtseweg 160, 3818 ES Amersfoort, the Netherlands

4 Department of Surgery, Onze Lieve Vrouwe Gasthuis Amsterdam, Oosterpark 9, 1091 AC Amsterdam, the Netherlands

5 Department of Surgery, Sint Antonius Hospital Nieuwegein, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands

6 Department of Surgery, Rode Kruis Hospital Beverwijk, Vondellaan 13, 1942 LE Beverwijk, the Netherlands

7 Department of Surgery, Kennemer Gasthuis Haarlem, Boerhaavelaan 22, 2035 RC Haarlem, the Netherlands

8 Department of Surgery, Laurentius Hospital Roermond, Mgr. Driessenstreet 6, 6043 CV Roermond, the Netherlands

9 Department of Surgery, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE Utrecht, the Netherlands

10 Department of Surgery, Atrium Medical Center Heerlen, Henri Dunantstraat 5, 6419 PC Heerlen, the Netherlands

11 Department of Surgery, Lucas Andreas Hospital Amsterdam, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands

12 Department of Surgery, Westfriesgasthuis Hoorn, Maelsonstraat 3,1624 NP Hoorn, the Netherlands

13 Department of Surgery, Jeroen Bosch Hospital 's-Hertogenbosch, Tolbrugstraat 11, 5211 RW 's-Hertogenbosch, the Netherlands

14 Department of Surgery, Maasstad Hospital Rotterdam, Olympiaweg 350,3078 HT Rotterdam, the Netherlands

15 Department of Surgery, Reinier de Graaf Hospital Voorburg, Fonteynenburghlaan 5A, 2275 Voorburg, the Netherlands

16 Department of Surgery, Medisch Spectrum Twente, Haaksbergerstraat 55, 7513 ER Enschede, the Netherlands

17 Department of Surgery, MC Zuiderzee Hospital Lelystad, Ziekenhuisweg 100, 8233 AA Lelystad, the Netherlands

18 Department of Surgery, Amphia Hospital Oosterhout, Pasteurlaan 9, 4900 AB Oosterhout, the Netherlands

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BMC Surgery 2010, 10:25  doi:10.1186/1471-2482-10-25

Published: 6 August 2010

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/design

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.

Discussion

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.

Trial Registration

(Trial register number: NTR1478)