Postoperative Complications and Mobilization Following Major Abdominal Surgery With Versus Without Fitness Tracker-based Feedback (EXPELLIARMUS): A Student-led Multicenter Randomized Controlled Clinical Trial of the CHIR-Net SIGMA Study Group.
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 Aug 2024
01 Aug 2024
Historique:
medline:
10
7
2024
pubmed:
10
7
2024
entrez:
10
7
2024
Statut:
ppublish
Résumé
To determine whether daily postoperative step goals and feedback through a fitness tracker (FT) reduce the rate of postoperative complications after surgery. Early and enhanced postoperative mobilization has been advocated to reduce postoperative complications, but it is unknown whether FT alone can reduce morbidity. EXPELLIARMUS was performed at 11 University Hospitals across Germany by the student-led clinical trial network SIGMA. Patients undergoing major abdominal surgery were enrolled, equipped with an FT, and randomly assigned to the experimental (visible screen) or control intervention (blackened screen). The experimental group received daily step goals and feedback through the FT. The primary end point was postoperative morbidity within 30 days using the Comprehensive Complication Index (CCI). All trial visits were performed by medical students in the hospital with the opportunity to consult a surgeon-facilitator who also obtained informed consent. After discharge, medical students performed the 30-day postoperative visit through telephone and electronic questionnaires. A total of 347 patients were enrolled. Baseline characteristics were comparable between the 2 groups. The mean age of patients was 58 years, and 71% underwent surgery for malignant disease, with the most frequent indications being pancreatic, colorectal, and hepatobiliary malignancies. Roughly one-third of patients underwent laparoscopic surgery. No imputation for the primary end point was necessary as data completeness was 100%. There was no significant difference in the CCI between the 2 groups in the intention-to-treat analysis (mean±SD CCI experimental group: 23±24 vs. control: 22±22; 95% CI: -6.1, 3.7; P=0.628). All secondary outcomes, including quality of recovery, 6-minute walking test, length of hospital stay, and step count until postoperative day 7 were comparable between the 2 groups. Daily step goals combined with FT-based feedback had no effect on postoperative morbidity. The EXPELLIARMUS shows that medical students can successfully conduct randomized controlled trials in surgery.
Sections du résumé
OBJECTIVE
OBJECTIVE
To determine whether daily postoperative step goals and feedback through a fitness tracker (FT) reduce the rate of postoperative complications after surgery.
BACKGROUND
BACKGROUND
Early and enhanced postoperative mobilization has been advocated to reduce postoperative complications, but it is unknown whether FT alone can reduce morbidity.
METHODS
METHODS
EXPELLIARMUS was performed at 11 University Hospitals across Germany by the student-led clinical trial network SIGMA. Patients undergoing major abdominal surgery were enrolled, equipped with an FT, and randomly assigned to the experimental (visible screen) or control intervention (blackened screen). The experimental group received daily step goals and feedback through the FT. The primary end point was postoperative morbidity within 30 days using the Comprehensive Complication Index (CCI). All trial visits were performed by medical students in the hospital with the opportunity to consult a surgeon-facilitator who also obtained informed consent. After discharge, medical students performed the 30-day postoperative visit through telephone and electronic questionnaires.
RESULTS
RESULTS
A total of 347 patients were enrolled. Baseline characteristics were comparable between the 2 groups. The mean age of patients was 58 years, and 71% underwent surgery for malignant disease, with the most frequent indications being pancreatic, colorectal, and hepatobiliary malignancies. Roughly one-third of patients underwent laparoscopic surgery. No imputation for the primary end point was necessary as data completeness was 100%. There was no significant difference in the CCI between the 2 groups in the intention-to-treat analysis (mean±SD CCI experimental group: 23±24 vs. control: 22±22; 95% CI: -6.1, 3.7; P=0.628). All secondary outcomes, including quality of recovery, 6-minute walking test, length of hospital stay, and step count until postoperative day 7 were comparable between the 2 groups.
CONCLUSIONS
CONCLUSIONS
Daily step goals combined with FT-based feedback had no effect on postoperative morbidity. The EXPELLIARMUS shows that medical students can successfully conduct randomized controlled trials in surgery.
Identifiants
pubmed: 38984800
doi: 10.1097/SLA.0000000000006232
pii: 00000658-202408000-00006
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
202-211Investigateurs
Mihaljevic André
(M)
Brindl Niall
(B)
Frey Pia-Elena
(F)
Friedrich Mirco
(F)
Gläser Nico
(G)
Gsenger Julia
(G)
Joos Maximilian
(J)
Kuner Charlotte
(K)
Leichtle Franziska
(L)
Pilgrim Max
(P)
Rösch Thomas
(R)
Schwab Marius
(S)
Studier-Fischer Alexander
(SF)
Tu Thomas
(T)
Doerr-Harim Colette
(DH)
Tenckhoff Solveig
(T)
Feißt Manuel
(F)
Klose Christina
(K)
Vey Johannes
(V)
Klose Christina
(K)
Beck Lydia
(B)
Brindl Niall
(B)
Dimitrova Radina-Ivaylova
(D)
Gläser Nico
(G)
Jerger Pia
(J)
Joos Maximilian
(J)
Kirschall Johanna
(K)
Kosmidou Anastasia
(K)
Kuner Charlotte
(K)
Leichtle Franziska
(L)
Röder Sonja
(R)
Schuhmacher Julia-Franziska
(S)
Schwab Marius
(S)
Seiboldt Till
(S)
Steidle Christoph
(S)
Wiesenberger Rico
(W)
Mihaljevic André
(M)
Doerr-Harim Colette
(DH)
Feißt Manuel
(F)
Axt Steffen
(A)
Höver Celine
(H)
Riecke Jana
(R)
Von Wedel Dario
(VW)
Wolff Constantin
(W)
Zollfrank Julia
(Z)
Babigian Julia
(B)
Bernhardt Robert
(B)
De Albuquerque Leinenbach Anne Marie Desiree
(AL)
Freimark Gerlinde
(F)
Hambitzer Felix
(H)
Katsara-Antonakea Niki
(KA)
Kloepfel Hanna
(K)
Kraume Johannes
(K)
Krug Niklas
(K)
Lewin Daniel
(L)
Schefold Marc
(S)
Schenkenberger Philip
(S)
Schmargon Rachel
(S)
Speckmann Clara Friederike
(S)
Weber Lisa-Marie
(W)
Woamey Jonas
(W)
Von Lipinski Vincent-Noah
(VL)
Neudecker Jens
(N)
Nguyen Viet Hoang
(N)
Al-Wassiti Mariam
(AW)
Kunik Patrick
(K)
Mertig Leon Niklas
(ML)
Faqar-Uz-Zaman Sara Fatima
(FU)
Berkarda Zeynep
(B)
Rocher Liesa Margarete
(RL)
Diener Markus
(D)
Gerdes Christoph
(G)
Heisler Sophie
(H)
Aicher Marie Louise
(AM)
Aperdannier Lena
(A)
Dölker Tammy
(D)
George Elisabeth
(G)
Möbus Christa
(M)
Plöger Hannah
(P)
Pilz Elisa
(P)
Plöger Ruben
(P)
Sassenrath Katharina
(S)
Scheele Dominik
(S)
Spinn Anna
(S)
Zech Christoph
(Z)
Von Heesen Maximilian
(VH)
Emons Georg
(E)
Kosch Ricardo
(K)
Gedeon Naomi
(G)
Linden Gideon
(L)
Kühn Kjell
(K)
Tachezy Michael
(T)
Psathakis Nikolas
(P)
Schroeter Andreas
(S)
Berndt Patrick
(B)
Gries Sarah
(G)
Gruber Lisa
(G)
Kleinert Julia
(K)
Messerer Jil
(M)
Preiser Claudia
(P)
Reimelt Alex Michael
(RA)
Schneider Hannah
(S)
Thavarasa Ajith
(T)
Werthschulte Moritz Daniel
(WM)
Vondran Florian
(V)
Beck Lydia
(B)
Braun Melissa
(B)
Kunder Charlotte
(K)
Seiboldt Till
(S)
Baumgärtner Kilian
(B)
Belosevic Amelie Sophie
(BA)
Betge Fynn
(B)
Blobner Sven
(B)
Böhnlein Jonas
(B)
Brindl Niall
(B)
Dunkel Yannick
(D)
Forster Sebastian
(F)
Friedrich Mirco
(F)
Funk Cornelius
(F)
Guo Huilin
(G)
Harapan Biyan Nathanael
(HB)
Henneken Sophie
(H)
Hubert Max
(H)
Iser Florian
(I)
Joos Maximilian
(J)
Josten Julia
(J)
Kaduk Carolin
(K)
Kapell Hannah
(K)
Kim Ji
(K)
None Young
Klein Lukas
(K)
Köhler Clara
(K)
Köpfer Felix
(K)
Lantwin Philippa
(L)
Liszowski Julia
(L)
Merz Daniela
(M)
Nguyen Linh-Cathrin
(N)
Parsons Zoe
(P)
Pfeiffer Vanessa
(P)
Prechal Daniela
(P)
Rösch Thomas
(R)
Rothenberger Rebecca
(R)
Rümmele-Vogt Anna
(RV)
Schmalzridt Jonathan
(S)
Schuhmacher Corinna
(S)
Sonntag Nikolai
(S)
Stille Malko
(S)
Studier-Fischer Alexander
(SF)
Töllner Maximilian
(T)
Van Eickels Deborah
(VE)
Waizy Omrahn
(W)
Wen Virginia
(W)
Klotz Rosa
(K)
Mihaljevic André
(M)
Gundlach Jan-Paul
(G)
Wehking Felix
(W)
Becker Thomas
(B)
Voigt Jonas
(V)
Schütze Leon
(S)
Fröhlich Melissa Kathrin
(FM)
Zehetmeier Fiona
(Z)
Stelzner Emma Sophia
(SE)
Skaberna Lisa
(S)
Steffen Patrizia
(S)
Zähring Lukas
(Z)
Riedel Anna
(R)
Herrle Florian
(H)
Meyer-Gehlen Corinna
(MG)
Obereisenbuchner Florian
(O)
Wehn Antonia
(W)
Fichaux Quentin
(F)
Michalski Morgana
(M)
Schönberger Max
(S)
Kappenberger Alina
(K)
Schirren Malte
(S)
Zimmermann Petra
(Z)
Erichsen Meret
(E)
Gläser Nico
(G)
Leichtle Franziska
(L)
Behr Jonathan
(B)
Gerich Samira
(G)
Hägele Janina
(H)
Hüsken Dominik
(H)
Ismail Majd
(I)
Karras Luise
(K)
Kastratovic Natalija
(K)
Kosmidou Anastasia
(K)
Lessing Pascal
(L)
Zaimi Marin
(Z)
Zhang Linyun
(Z)
Denzinger Maximilian
(D)
Graf Sandra
(G)
Heger Patrick
(H)
Nasir Nadir
(N)
Radmann Dan
(R)
Informations de copyright
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The author report no conflict of interest.
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