Clinical trial NCT04502654: Rehabilitation for Thoracoscopic Lobectomy
Official title: Postoperative Functional Recovery After Fast-track VATS Lobectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Rehabilitation
Exercise
Pain, Postoperative
Post Discharge
Keywords: Functional recovery
Enhanced recovery after surgery
Video-assisted thoracoscopic surgery
Lobectomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be submitted to video-assisted thoracoscopic surgery lobectomy.

Brief summary: The main aim of this research is to compare the functional recovery after discharge with the preoperative physical activity as a hypothesis generating study.


Eligibility criteria: Inclusion Criteria:

* VATS-L
* Speaks and understands Danish or English.
* Informed consent obtained

Exclusion Criteria:

* Co-VATS-L.
* on the wheelchair.
* Living in nurse home.
* Using rollator to assist to walk.
* Unwilling to place the Actiwatch 2 or execute PPE.

Primary outcomes:
measure: Length of functional rehabilitation
timeFrame: Through study completion, minimum 7 days
Secondary outcomes:
measure: Quality of recovery
timeFrame: Through study completion, an average of 14 days
measure: The quantization of fatigue
timeFrame: Through study completion, an average of 14 days
measure: The quantization of pain
timeFrame: Through study completion, an average of 14 days
measure: The quantization of vomiting.
timeFrame: Through study completion, an average of 14 days
measure: The quantization of nausea.
timeFrame: Through study completion, an average of 14 days
measure: The quantization of Activity Counts
timeFrame: Through study completion, an average of 14 days
measure: Length of sleep time
timeFrame: Through study completion, an average of 14 days
measure: The quantization of morbidity
timeFrame: up to 30 days
measure: The quantization of mortality
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lin Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, Professor, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Rene H Petersen, Professor, MD, PhD
role: STUDY_CHAIR
References:
citation: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
citation: Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.
citation: Yang CJ, Kumar A, Deng JZ, Raman V, Lui NS, D'Amico TA, Berry MF. A National Analysis of Short-term Outcomes and Long-term Survival Following Thoracoscopic Versus Open Lobectomy for Clinical Stage II Non-Small-Cell Lung Cancer. Ann Surg. 2021 Mar 1;273(3):595-605. doi: 10.1097/SLA.0000000000003231.
citation: Marijic P, Walter J, Schneider C, Schwarzkopf L. Cost and survival of video-assisted thoracoscopic lobectomy versus open lobectomy in lung cancer patients: a propensity score-matched study. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):92-99. doi: 10.1093/ejcts/ezz157.
citation: Iwata H, Shirahashi K, Yamamoto H, Marui T, Matsumoto S, Mizuno Y, Matsumoto M, Mitta S, Miyamoto Y, Komuro H. Propensity score-matching analysis of hybrid video-assisted thoracoscopic surgery and thoracoscopic lobectomy for clinical stage I lung cancerdagger. Eur J Cardiothorac Surg. 2016 Apr;49(4):1063-7. doi: 10.1093/ejcts/ezv296. Epub 2015 Aug 30.
citation: Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
citation: Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
citation: Kehlet H. Enhanced postoperative recovery: good from afar, but far from good? Anaesthesia. 2020 Jan;75 Suppl 1:e54-e61. doi: 10.1111/anae.14860.
citation: Wang KY, Chang NW, Wu TH, Hsu CC, Lee YH, Lee SC. Post-discharge health care needs of patients after lung cancer resection. J Clin Nurs. 2010 Sep;19(17-18):2471-80. doi: 10.1111/j.1365-2702.2010.03298.x.
citation: Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
citation: Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg. 2001 Aug;136(8):917-21. doi: 10.1001/archsurg.136.8.917.
citation: Luna IE, Kehlet H, Wede HR, Hoevsgaard SJ, Aasvang EK. Objectively measured early physical activity after total hip or knee arthroplasty. J Clin Monit Comput. 2019 Jun;33(3):509-522. doi: 10.1007/s10877-018-0185-5. Epub 2018 Jul 23.
citation: Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
citation: Timmerman JGJ, Dekker-van Weering MGHM, Wouters MWJMM, Stuiver MMM, de Kanter WW, Vollenbroek-Hutten MMRM. Physical behavior and associations with health outcomes in operable NSCLC patients: A prospective study. Lung Cancer. 2018 May;119:91-98. doi: 10.1016/j.lungcan.2018.03.006. Epub 2018 Mar 9.
citation: Wolvers MDJ, Bussmann JBJ, Bruggeman-Everts FZ, Boerema ST, van de Schoot R, Vollenbroek-Hutten MMR. Physical Behavior Profiles in Chronic Cancer-Related Fatigue. Int J Behav Med. 2018 Feb;25(1):30-37. doi: 10.1007/s12529-017-9670-3.