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

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	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.
Aim:	Direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising HRQoL, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.
Methods:	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.
Reason for International Trial:	-

Trial Details