TY - JOUR

T1 - Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA)

T2 - study protocol for a randomised controlled trial

AU - Thornell, Anders

AU - Angenete, Eva

AU - Gonzales, Elisabeth

AU - Heath, Jane

AU - Jess, Per

AU - Läckberg, Zoltan

AU - Ovesen, Henrik

AU - Rosenberg, Jacob

AU - Skullman, Stefan

AU - Haglind, Eva

AU - Ssorg, Scandinavian Surgical Outcome Research Group

AU - Thornell, Anders

AU - Angenete, Eva

AU - Gonzales, Elisabeth

AU - Heath, Jane

AU - Jess, Per

AU - Läckberg, Zoltan

AU - Ovesen, Henrik

AU - Rosenberg, Jacob

AU - Skullman, Stefan

AU - Haglind, Eva

AU - Scandinavian Surgical Outcomes Research Group, SSORG

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

U2 - 10.1186/1745-6215-12-186

DO - 10.1186/1745-6215-12-186

M3 - Journal article

C2 - 21806795

VL - 12

SP - 186

EP - 190

JO - Trials

JF - Trials

SN - 1745-6215

ER -