DIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.

Rationale:

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 impairing quality of life and increasing costs due to multiple specialist consultations, pain medication and sick-leave from paid work.

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, optimalising QoL, 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.



Objective:

The objective is to compare the outcome of elective resection of the diseased colon segment to conservative management for patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis.



Study design:

Multicenter randomised clinical trial with a follow-up of 3 years.



Study population:

Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years.



Intervention:

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.



Main study parameters/endpoints:

Quality of life measured by the Gastro-intestinal Quality of Life Index, Shortform-36, EuroQol-5D and visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs.

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 impairing quality of life and increasing costs due to multiple specialist consultations, pain medication and sick-leave from paid work.
Both conservative management and elective sigmoid resection for 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, optimalising QoL, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.

Baseline, 3, 6, 9, 12, 24 and 36 months.

Conservative treatment:

Patients randomised for conservative treatment are treated according to the current daily practice. In other words, conservative treatment is determined by the preferences of the treating physician. Conservative treatment may consist of expectant management, antibiotics and/or analgetics. Should there be radiologic evidence for the presence of pericolic abscesses, percutaneous drainage may be performed depending on the size and opinion of the local radiologist regarding accessibility.



Elective surgery:

Patients randomised for elective surgery will undergo an elective colonic resection within approximately 2 months of follow-up. In the interval between randomisation and elective surgery, patients are treated conservatively (see above). Intentionally, a laparoscopic approach is used. The extent to which the colon is resected in the proximal direction should cover the entire macroscopically involved colon. In other words, the proximal resection line should be where no diverticula exist or at the level where a considerable decline in number of diverticula is noted. Distally, the margin of resection should be where the taenia coli splay out onto the upper rectum. After resection a primary anastomosis will be performed between the distal colon and rectum.