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


- candidate number4013
- NTR NumberNTR1478
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-sep-2008
- Secondary IDsR-08.28M/DIRECT 
- Public TitleDIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.
- Scientific TitleDIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.
- ACRONYMDIRECT-trial
- hypothesisPersisting 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.
- Healt Condition(s) or Problem(s) studiedDiverticulitis, Relapse
- Inclusion criteria1. Age 18-75 years;
2. Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after a well documented (CT-scan or sonography) episode of diverticulitis.
Persisting abdominal complaints may include patients with:
A. Continuing lower left abdominal pain AND/OR persistent change in bowel habits AND/OR persistent blood loss;
B. Symptoms must exist longer than 3 months after a previous episode of diverticulitis.
Frequently recurring diverticulitis is defined as:
A. Three or more diverticulitis recurrences within 2 years;
B. A minimal interval of 3 months between the recurrences is mandatory.
3. Persisting abdominal complaints and/or frequently recurring diverticulitis must be accompanied by inflammatory changes (CT-scan or sonography) in the bowel wall: Bowel-wall thickening with or without abscess;
4. ASA I -III.
- Exclusion criteria1. Patients with elective or emergency surgery for acute diverticulitis in the past;
2. Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula);
3. Patients with colorectal malignancies;
4. Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2014
- Target number of participants214
- InterventionsConservative 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.
- Primary outcomeQuality of life (QoL) objectified primarily by the Gastro-intestinal Quality of life Index (GIQLI) and secondarily by EuroQol-5D (EQ-5D), Short-form 36 (SF-36) and Visual Analogue Score (VAS) for pain. Patients are also asked to point out on a 7 point scale whether their health/complaints have improved or deteriorated.
- Secondary outcome1. Mortality;
2. Morbidity;
3. (In)Direct (non-)health care costs.
- TimepointsBaseline, 3, 6, 9, 12, 24 and 36 months.
- Trial web sitewww.direct-trial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESB.J.M. Wall, van de
- CONTACT for SCIENTIFIC QUERIESB.J.M. Wall, van de
- Sponsor/Initiator Meander Medical Center Amersfoort
- Funding
(Source(s) of Monetary or Material Support)
Meander Medical Center Amersfoort
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD20-sep-2008 - 22-apr-2010


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