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

Abstract

BackgroundPersisting 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/designThe 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.DiscussionConsidering 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)

Recurrences and Ongoing Complaints of Diverticulitis; Results of a Survey among Gastroenterologists and Surgeons

“…Even though national and international guidelines exist and all respondents are aware of the content, the treatment of diverticulitis differs [10,11,12,13,14,15]. As guidelines are required to change current clinical practice, so is the assessment of barriers to adhere to these guidelines.…”

“…Therefore, we expected to find a marked difference in every field between surgeons and gastroenterologists; however, this was not the case. Treatment is becoming more and more a tailor-made decision [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26]. The use of mesalazine, which is opted by the greater part of participating gastroenterologists, remains a subject of debate.…”

“…Consequently, current guidelines are not uniform in their suggestions [10,11,12,13,14,15]. In 2000, the standard task force of the American Society of Colon and Rectal surgeons recommended that a sigmoidectomy be performed after a second episode of diverticulitis [10].…”

National complicated acute diverticulitis (CADS) study: a protocol for a prospective observational scoping study for acute diverticulitis

“…Good-quality randomised controlled trials are few and their patient numbers are small. [10][11][12][13][14][15][16] The latest published review by McDermott et al 17 looking into laparoscopic and open management in diverticulitis, found trials with a cumulative of only 800 patients worldwide managed laparoscopically, has concluded that more data are needed.…”

Contemporary Review of Risk‐Stratified Management in Acute Uncomplicated and Complicated Diverticulitis

“…[44,45] Results from the DIRECT trial (NTR1478), a randomised comparison of elective resection for recurrent diverticulitis versus non-operative treatment, are expected following the interruption of the trial after interim analysis. [46] Given the relative confusion that exists about the natural history of uncomplicated diverticulitis, it is recommended that the decision to offer an elective colectomy should be individualized.…”