DIRECT: Diverticulitis recurrences or continuing symptoms

Trial Overview

Acronym	DIRECT
Number	NTR1478
Protocol Link	https://www.researchgate.net/publication/45535672_DIRECT_trial_Diverticulitis_recurrences_or_continuing_symptoms_Operative_versus_conservative_treatment_A_multicenter_randomised_clinical_trial
Public Trial Registry Link	http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1478 - http://link.springer.com/article/10.1007/s00384-013-1694-9
Published Results Link	http://www.thelancet.com/pdfs/journals/langas/PIIS2468-1253(16)30109-1.pdf
Status	Closed
Category	Miscellaneous
Treatment Course	Surgery

Trial Description

Patients presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomized to either conservative treatment or elective resection. The primary outcome is health related quality of life measured by the GIQL 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.

Chief Investigator

Bryan JM van de Wall Dr

Profile Link

Lead Centre

Meander Medisch Centrum Maatweg 3 Amersfoort 3813 The Netherlands

Website

Funding Sponsors

1. ZonMW, the Netherlands Organisation for Health Research and Development