Abstract
Background: Perforated diverticulitis is a condition associated with substantial morbidity. Recently published
reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised
study has published any results.
Methods: DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional
Hartmann’s Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints
consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients
are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is
included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally,
placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months.
A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40).
Discussion: HP is associated with a high rate of complication. Not only does the primary operation entail
complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of
treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe,
minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer reoperations,
decreased morbidity, mortality, costs and increased quality of life.
reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised
study has published any results.
Methods: DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional
Hartmann’s Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints
consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients
are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is
included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally,
placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months.
A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40).
Discussion: HP is associated with a high rate of complication. Not only does the primary operation entail
complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of
treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe,
minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer reoperations,
decreased morbidity, mortality, costs and increased quality of life.
Originalsprog | Engelsk |
---|---|
Tidsskrift | Trials |
Vol/bind | 12 |
Sider (fra-til) | 186-90 |
ISSN | 1745-6215 |
DOI | |
Status | Udgivet - 2011 |