Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls

Boukje T. Bootsma; Daitlin E. Huisman; Muriel Reudink; Anne de Wit; Carlo Feo; Jens-Peter Hering; Roel Hompes; Niels Komen; Emmanuel A. G. L. Lagae; Tim Lubbers; Connie S. Mueler; Stephanie L. van der Pas; Laurents P. S. Stassen; Jurre Stens; Dirk J. A. Sonneveld; Emiel G. G. Verdaasdonk; Colin van Velzen; Johannes A. Wegdam; Bob van Wely; Gerrit D. Slooter; Freek Daams

doi:10.1097/SP9.0000000000000014

Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls

Boukje T. Bootsma^*, Daitlin E. Huisman, Muriel Reudink, Anne de Wit, Carlo Feo, Jens-Peter Hering, Roel Hompes, Niels Komen, Emmanuel A. G. L. Lagae, Tim Lubbers, Connie S. Mueler, Stephanie L. van der Pas, Laurents P. S. Stassen, Jurre Stens, Dirk J. A. Sonneveld, Emiel G. G. Verdaasdonk, Colin van Velzen, Johannes A. Wegdam, Bob van Wely, Gerrit D. SlooterFreek Daams

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient's intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.

Original language	English
Pages (from-to)	73-80
Number of pages	8
Journal	International Journal of Surgery Protocols
Volume	28
Issue number	3
DOIs	https://doi.org/10.1097/SP9.0000000000000014
Publication status	Published - 2024

Keywords

anastomotic leakage
perioperative care
colorectal surgery
RISK-FACTORS
CURATIVE RESECTION
ANTERIOR RESECTION
PREDICTIVE FACTORS
COLORECTAL-CANCER
RECTAL-CANCER
SURVIVAL

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10.1097/SP9.0000000000000014Licence: CC BY-NC-ND

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Bootsma, B. T., Huisman, D. E., Reudink, M., de Wit, A., Feo, C., Hering, J.-P., Hompes, R., Komen, N., Lagae, E. A. G. L., Lubbers, T., Mueler, C. S., Pas, S. L. V. D., Stassen, L. P. S., Stens, J., Sonneveld, D. J. A., Verdaasdonk, E. G. G., van Velzen, C., Wegdam, J. A., van Wely, B., ... Daams, F. (2024). Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls. International Journal of Surgery Protocols, 28(3), 73-80. https://doi.org/10.1097/SP9.0000000000000014

@article{4d12b2ff547546369609a037b90d069e,

title = "Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls",

abstract = "Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient's intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.",

keywords = "anastomotic leakage, perioperative care, colorectal surgery, RISK-FACTORS, CURATIVE RESECTION, ANTERIOR RESECTION, PREDICTIVE FACTORS, COLORECTAL-CANCER, RECTAL-CANCER, SURVIVAL",

author = "Bootsma, {Boukje T.} and Huisman, {Daitlin E.} and Muriel Reudink and {de Wit}, Anne and Carlo Feo and Jens-Peter Hering and Roel Hompes and Niels Komen and Lagae, {Emmanuel A. G. L.} and Tim Lubbers and Mueler, {Connie S.} and Pas, {Stephanie L. van der} and Stassen, {Laurents P. S.} and Jurre Stens and Sonneveld, {Dirk J. A.} and Verdaasdonk, {Emiel G. G.} and {van Velzen}, Colin and Wegdam, {Johannes A.} and {van Wely}, Bob and Slooter, {Gerrit D.} and Freek Daams",

year = "2024",

doi = "10.1097/SP9.0000000000000014",

language = "English",

volume = "28",

pages = "73--80",

journal = "International Journal of Surgery Protocols",

issn = "2468-3574",

publisher = "IJS Publishing Group",

number = "3",

}

Bootsma, BT, Huisman, DE, Reudink, M, de Wit, A, Feo, C, Hering, J-P, Hompes, R, Komen, N, Lagae, EAGL, Lubbers, T , Mueler, CS, Pas, SLVD, Stassen, LPS, Stens, J, Sonneveld, DJA, Verdaasdonk, EGG, van Velzen, C, Wegdam, JA, van Wely, B, Slooter, GD & Daams, F 2024, 'Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls', International Journal of Surgery Protocols, vol. 28, no. 3, pp. 73-80. https://doi.org/10.1097/SP9.0000000000000014

Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls. / Bootsma, Boukje T.; Huisman, Daitlin E.; Reudink, Muriel et al.
In: International Journal of Surgery Protocols, Vol. 28, No. 3, 2024, p. 73-80.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK

T2 - study protocol for an international, multicenter open-label trial with historical controls

AU - Bootsma, Boukje T.

AU - Huisman, Daitlin E.

AU - Reudink, Muriel

AU - de Wit, Anne

AU - Feo, Carlo

AU - Hering, Jens-Peter

AU - Hompes, Roel

AU - Komen, Niels

AU - Lagae, Emmanuel A. G. L.

AU - Lubbers, Tim

AU - Mueler, Connie S.

AU - Pas, Stephanie L. van der

AU - Stassen, Laurents P. S.

AU - Stens, Jurre

AU - Sonneveld, Dirk J. A.

AU - Verdaasdonk, Emiel G. G.

AU - van Velzen, Colin

AU - Wegdam, Johannes A.

AU - van Wely, Bob

AU - Slooter, Gerrit D.

AU - Daams, Freek

PY - 2024

Y1 - 2024

N2 - Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient's intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.

AB - Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient's intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.

KW - anastomotic leakage

KW - perioperative care

KW - colorectal surgery

KW - RISK-FACTORS

KW - CURATIVE RESECTION

KW - ANTERIOR RESECTION

KW - PREDICTIVE FACTORS

KW - COLORECTAL-CANCER

KW - RECTAL-CANCER

KW - SURVIVAL

U2 - 10.1097/SP9.0000000000000014

DO - 10.1097/SP9.0000000000000014

M3 - Article

SN - 2468-3574

VL - 28

SP - 73

EP - 80

JO - International Journal of Surgery Protocols

JF - International Journal of Surgery Protocols

IS - 3

ER -

Enhanced perioperative care for the prevention of anastomotic leakage - DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls

Abstract

Keywords

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