Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

Anders Thornell; Eva Angenete; Elisabeth Gonzales; Jane Heath; Per Jess; Zoltan Läckberg; Henrik Ovesen; Jacob Rosenberg; Stefan Skullman; Eva Haglind; Scandinavian Surgical Outcome Research Group Ssorg; Anders Thornell; Eva Angenete; Elisabeth Gonzales; Jane Heath; Per Jess; Zoltan Läckberg; Henrik Ovesen; Jacob Rosenberg; Stefan Skullman; Eva Haglind; Scandinavian Surgical Outcomes Research Group, SSORG

doi:10.1186/1745-6215-12-186

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

Anders Thornell, Eva Angenete, Elisabeth Gonzales, Jane Heath, Per Jess, Zoltan Läckberg, Henrik Ovesen, Jacob Rosenberg, Stefan Skullman, Eva Haglind, Scandinavian Surgical Outcome Research Group Ssorg, Anders Thornell, Eva Angenete, Elisabeth Gonzales, Jane Heath, Per Jess, Zoltan Läckberg, Henrik Ovesen, Jacob Rosenberg, Stefan SkullmanEva Haglind, Scandinavian Surgical Outcomes Research Group, SSORG

62 Citationer (Scopus)

Abstract

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 re-operations, decreased morbidity, mortality, costs and increased quality of life.Trial registration: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	12
Sider (fra-til)	186-90
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-12-186 https://doi.org/10.1186/1745-6215-12-186
Status	Udgivet - 1 aug. 2011

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Thornell, A., Angenete, E., Gonzales, E., Heath, J., Jess, P., Läckberg, Z., Ovesen, H., Rosenberg, J., Skullman, S., Haglind, E., Ssorg, S. S. O. R. G., Thornell, A., Angenete, E., Gonzales, E., Heath, J., Jess, P., Läckberg, Z., Ovesen, H., Rosenberg, J., ... Scandinavian Surgical Outcomes Research Group, SSORG (2011). Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial. Trials, 12, 186-90. https://doi.org/10.1186/1745-6215-12-186, https://doi.org/10.1186/1745-6215-12-186

Thornell, A, Angenete, E, Gonzales, E, Heath, J, Jess, P, Läckberg, Z, Ovesen, H, Rosenberg, J, Skullman, S, Haglind, E, Ssorg, SSORG, Thornell, A, Angenete, E, Gonzales, E, Heath, J, Jess, P, Läckberg, Z, Ovesen, H, Rosenberg, J, Skullman, S, Haglind, E & Scandinavian Surgical Outcomes Research Group, SSORG 2011, 'Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial', Trials, bind 12, s. 186-90. https://doi.org/10.1186/1745-6215-12-186, https://doi.org/10.1186/1745-6215-12-186

@article{aa05e1bb4d1d46a9a31e86b99d97e046,

title = "Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial",

abstract = "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 re-operations, decreased morbidity, mortality, costs and increased quality of life.Trial registration: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.",

author = "Anders Thornell and Eva Angenete and Elisabeth Gonzales and Jane Heath and Per Jess and Zoltan L{\"a}ckberg and Henrik Ovesen and Jacob Rosenberg and Stefan Skullman and Eva Haglind and Ssorg, {Scandinavian Surgical Outcome Research Group} and Anders Thornell and Eva Angenete and Elisabeth Gonzales and Jane Heath and Per Jess and Zoltan L{\"a}ckberg and Henrik Ovesen and Jacob Rosenberg and Stefan Skullman and Eva Haglind and Jacob Rosenberg",

year = "2011",

month = aug,

day = "1",

doi = "10.1186/1745-6215-12-186",

language = "English",

volume = "12",

pages = "186--90",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

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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 - 2011/8/1

Y1 - 2011/8/1

N2 - 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 re-operations, decreased morbidity, mortality, costs and increased quality of life.Trial registration: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

AB - 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 re-operations, decreased morbidity, mortality, costs and increased quality of life.Trial registration: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

U2 - 10.1186/1745-6215-12-186

DO - 10.1186/1745-6215-12-186

M3 - Journal article

C2 - 21806795

SN - 1745-6215

VL - 12

SP - 186

EP - 190

JO - Trials

JF - Trials

ER -

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

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