Diverticulitis - laparoscopic lavage versus resection (Hartman procedure) for acute diverticulitis with peritonitis: the DILALA trial

Completed

• Conditions: Perforated diverticulitis; Digestive System; Other diseases of stomach and duodenum

• Registration Number: ISRCTN82208287
• Lead Sponsor: Sahlgrenska University Hospital (Sweden) - Department of Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-30
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients with acute diverticulitis (no age limits, either sex)
2. Intra-abdominal fluid or gas on computed tomography (CT)
3. Decision by the surgeon to perform emergency surgery
4. Possible to operate in regard to concomitant disease
5. Informed consent

Amended 10/05/2010:
The ethical committees have given permission for patients who are unable to give informed consent due to the diverticulitis, to be included until such time postoperatively when they can be duly informed and then give an informed consent or withdraw the presumed consent.

Exclusion Criteria

Current exclusion criteria as of 30/06/2011:
1.
1.1. Not possible to operate due to concomitant disease
1.2. Participation in other randomized trials in conflict with the protocol and end-points of the DILALA trial
2. Randomization: criteria
2.1. Perforated diverticulitis Hinchey grad III at diagnostic laparoscopy
3. Exclusion from randomization: criteria
3.1. Hinchey grade I - II at laparoscopy i.e. no free fluid/pus in the abdomen ? no further surgical procedure
3.2. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation
3.3. Other pathology than perforated diverticulitis, for example perforated appendicitis or stomach ulcer.
4. Exclusion after randomization
4.1. Withdrawn consent
4.2. Cancer diagnosed in resected specimen (only possible in randomised to Hartmann?s procedure)
4.3. Cancer diagnosed at colonoscopy after initial episode
5. Intention to treat
5.1. All patients randomised in accordance with randomization criteria and not excluded correctly after randomization (criteria for this see above) will be analysed in group of randomization. This means that patients randomized to laparocopic lavage and converted to open surgery will be analysed in the 'laparoscopic lavage group'

Previous exclusion criteria:
1. Patients not possible to operate due to concomitant disease
2. Hinchey grade I - II at laparoscopy i.e. no free fluid - no further surgical procedure
3. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation
4. Participation in other randomised trials in conflict with the protocol and end-points of this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified