Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial

Nicole van der Wielen; Freek Daams; Riccardo Rosati; Paolo Parise; J. rgen Weitz; Christoph Reissfelder; Ismael Diez del Val; Carlos Loureiro; Purificación Parada-González; Elena Pintos-Martínez; Francisco Mateo Vallejo; Carlos Medina Achirica; Andrés Sánchez-Pernaute; Adriana Ruano Campos; Luigi Bonavina; Emanuele L. G. Asti; Alfredo Alonso Poza; Carlos Gilsanz; Magnus Nilsson; Mats Lindblad; Suzanne S. Gisbertz; Mark I. van Berge Henegouwen; Uberto Fumagalli Romario; Stefano de Pascale; Khurshid Akhtar; H. Jaap Bonjer; Miguel A. Cuesta; Donald L. van der Peet; Jennifer Straatman

doi:10.1016/j.ejso.2021.08.031

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial

Nicole van der Wielen^*
, Freek Daams
, Riccardo Rosati
, Paolo Parise
, J. rgen Weitz
, Christoph Reissfelder
, Ismael Diez del Val
, Carlos Loureiro
, Purificación Parada-González
, Elena Pintos-Martínez
, Francisco Mateo Vallejo
, Carlos Medina Achirica
, Andrés Sánchez-Pernaute
, Adriana Ruano Campos
, Luigi Bonavina
, Emanuele L. G. Asti
, Alfredo Alonso Poza
, Carlos Gilsanz
, Magnus Nilsson
, Mats Lindblad

Suzanne S. Gisbertz, Mark I. van Berge Henegouwen, Uberto Fumagalli Romario, Stefano de Pascale, Khurshid Akhtar, H. Jaap Bonjer, Miguel A. Cuesta, Donald L. van der Peet^*, Jennifer Straatman

^*Corresponding author for this work

Amsterdam UMC - University of Amsterdam
Viral Evolution and Transmission Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Milan, Italy
Division of Hematology and Hemostaseology, Department of Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany
Heidelberg University
Hospital de Basurto
University of Santiago de Compostela
Department of Surgery, Hospital de Jerez, Jerez de la Frontera, Spain
Complutense University
IRCCS Policlinico San Donato
Department of Surgery, Hospital del Sureste, Madrid, Spain
Karolinska Institutet
IRCCS Istituto Europeo di Oncologia - Milano
Northern Care Alliance NHS Group
University of Amsterdam
From the Neuroimaging Research Unit, Division of Neuroscience (P.P.), and Neurology Unite (P.P.), IRCCS San Raffaele Scientific Institute, Milan, Italy; and Department of Anatomy and Neurosciences (M.M.S.), MS Center Amsterdam, Amsterdam Neuroscience, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands
Medizinische Klinik und Poliklinik I, University Hospital Carl Gustav Carus, Dresden Germany
Universitätsmedizin Mannheim
Hospital Jerez de la Frontera
CIBERONC (Instituto de Investigación Sanitaria San Carlos)
Hospital del Sureste
Karolinska University Hospital
Salford Royal NHS FoundationTrust

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Abstract

Introduction: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. Materials and methods: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60–90) in the open group and 68 (50–83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7–83,3) in the open group and 58,3 (35,4–66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. Conclusion: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

Original language	English
Pages (from-to)	553-560
Number of pages	8
Journal	European journal of surgical oncology
Volume	48
Issue number	3
Early online date	2021
DOIs	https://doi.org/10.1016/j.ejso.2021.08.031
Publication status	Published - Mar 2022

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Gastric cancer
Minimally invasive gastrectomy
Open gastrectomy
Quality of life

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van der Wielen, N., Daams, F., Rosati, R., Parise, P., Weitz, J. R., Reissfelder, C., Diez del Val, I., Loureiro, C., Parada-González, P., Pintos-Martínez, E., Vallejo, F. M., Achirica, C. M., Sánchez-Pernaute, A., Campos, A. R., Bonavina, L., Asti, E. L. G., Poza, A. A., Gilsanz, C., Nilsson, M., ... Straatman, J. (2022). Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial. European journal of surgical oncology, 48(3), 553-560. https://doi.org/10.1016/j.ejso.2021.08.031

@article{8af2f5a6941d40bebb4f3e9bd563f470,

title = "Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial",

abstract = "Introduction: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. Materials and methods: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80\% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60–90) in the open group and 68 (50–83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7–83,3) in the open group and 58,3 (35,4–66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. Conclusion: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.",

keywords = "Gastric cancer, Minimally invasive gastrectomy, Open gastrectomy, Quality of life",

author = "\{van der Wielen\}, Nicole and Freek Daams and Riccardo Rosati and Paolo Parise and Weitz, \{J. rgen\} and Christoph Reissfelder and \{Diez del Val\}, Ismael and Carlos Loureiro and Purificaci{\'o}n Parada-Gonz{\'a}lez and Elena Pintos-Mart{\'i}nez and Vallejo, \{Francisco Mateo\} and Achirica, \{Carlos Medina\} and Andr{\'e}s S{\'a}nchez-Pernaute and Campos, \{Adriana Ruano\} and Luigi Bonavina and Asti, \{Emanuele L. G.\} and Poza, \{Alfredo Alonso\} and Carlos Gilsanz and Magnus Nilsson and Mats Lindblad and Gisbertz, \{Suzanne S.\} and \{van Berge Henegouwen\}, \{Mark I.\} and Romario, \{Uberto Fumagalli\} and \{de Pascale\}, Stefano and Khurshid Akhtar and Bonjer, \{H. Jaap\} and Cuesta, \{Miguel A.\} and \{van der Peet\}, \{Donald L.\} and Jennifer Straatman",

note = "Funding Information: The STOMACH trial received funding by Fonds NutsOhra (FNO) . This was given to the department of gastro-intestinal surgery at Amsterdam University Medical Center, location VU university. All other authors declare no conflict of interest. Funding Information: The STOMACH trial received funding by Fonds NutsOhra (FNO). This was given to the department of gastro-intestinal surgery at Amsterdam University Medical Center, location VU university. All other authors declare no conflict of interest. Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2022",

month = mar,

doi = "10.1016/j.ejso.2021.08.031",

language = "English",

volume = "48",

pages = "553--560",

journal = "European journal of surgical oncology",

issn = "0748-7983",

publisher = "W.B. Saunders Ltd",

number = "3",

}

van der Wielen, N, Daams, F, Rosati, R, Parise, P, Weitz, JR, Reissfelder, C, Diez del Val, I, Loureiro, C, Parada-González, P, Pintos-Martínez, E, Vallejo, FM, Achirica, CM, Sánchez-Pernaute, A, Campos, AR, Bonavina, L, Asti, ELG, Poza, AA, Gilsanz, C, Nilsson, M, Lindblad, M, Gisbertz, SS , van Berge Henegouwen, MI, Romario, UF, de Pascale, S, Akhtar, K, Bonjer, HJ , Cuesta, MA , van der Peet, DL & Straatman, J 2022, 'Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial', European journal of surgical oncology, vol. 48, no. 3, pp. 553-560. https://doi.org/10.1016/j.ejso.2021.08.031

TY - JOUR

T1 - Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial

AU - van der Wielen, Nicole

AU - Daams, Freek

AU - Rosati, Riccardo

AU - Parise, Paolo

AU - Weitz, J. rgen

AU - Reissfelder, Christoph

AU - Diez del Val, Ismael

AU - Loureiro, Carlos

AU - Parada-González, Purificación

AU - Pintos-Martínez, Elena

AU - Vallejo, Francisco Mateo

AU - Achirica, Carlos Medina

AU - Sánchez-Pernaute, Andrés

AU - Campos, Adriana Ruano

AU - Bonavina, Luigi

AU - Asti, Emanuele L. G.

AU - Poza, Alfredo Alonso

AU - Gilsanz, Carlos

AU - Nilsson, Magnus

AU - Lindblad, Mats

AU - Gisbertz, Suzanne S.

AU - van Berge Henegouwen, Mark I.

AU - Romario, Uberto Fumagalli

AU - de Pascale, Stefano

AU - Akhtar, Khurshid

AU - Bonjer, H. Jaap

AU - Cuesta, Miguel A.

AU - van der Peet, Donald L.

AU - Straatman, Jennifer

N1 - Funding Information: The STOMACH trial received funding by Fonds NutsOhra (FNO) . This was given to the department of gastro-intestinal surgery at Amsterdam University Medical Center, location VU university. All other authors declare no conflict of interest. Funding Information: The STOMACH trial received funding by Fonds NutsOhra (FNO). This was given to the department of gastro-intestinal surgery at Amsterdam University Medical Center, location VU university. All other authors declare no conflict of interest. Publisher Copyright: © 2021 The Authors

PY - 2022/3

Y1 - 2022/3

N2 - Introduction: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. Materials and methods: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60–90) in the open group and 68 (50–83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7–83,3) in the open group and 58,3 (35,4–66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. Conclusion: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

AB - Introduction: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. Materials and methods: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60–90) in the open group and 68 (50–83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7–83,3) in the open group and 58,3 (35,4–66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. Conclusion: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

KW - Gastric cancer

KW - Minimally invasive gastrectomy

KW - Open gastrectomy

KW - Quality of life

UR - https://www.scopus.com/pages/publications/85114423513

U2 - 10.1016/j.ejso.2021.08.031

DO - 10.1016/j.ejso.2021.08.031

M3 - Article

C2 - 34503850

SN - 0748-7983

VL - 48

SP - 553

EP - 560

JO - European journal of surgical oncology

JF - European journal of surgical oncology

IS - 3

ER -

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial

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Keywords

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