Rehabilitation for Thoracoscopic Lobectomy

Pain, Postoperative Clinical Trial

Official title:

Postoperative Functional Recovery After Fast-track VATS Lobectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502654
• Other study ID #: H-20041489
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: July 21, 2021

Study information

• Verified date: August 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Lung Neoplasms
• Pain, Postoperative
• Post Discharge
• Rehabilitation

Intervention

Device:
• Actiwatch 2 (Philips Respironics, Murrysville, USA)
Actiwatch 2 is an unobtrusive, waterproof, light sensor and wrist-worn device (weight 16.0g, size 4.3 cm* 2.3 cm* 1.0 cm), containing a tri-axial accelerometer able to records a digitally integrated measure of gross motor activity (a piezoelectric sensor to detect vertical accelerations at the wrist between 0.5 and 2.0 g with a frequency response range between 0.35-7.5 Hz). Activity counts from the device reflect the peak acceleration detected over each epoch and are used in determining sleep and wake intervals, which can be used to rest-activity patterns, quality of physical activity and sleep for 15-60 seconds/ epoch, 24 hours/ day, 2 weeks.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (15)

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. Review. — View 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. — View 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®) 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. Review. — View Citation

Bendixen M, Jørgensen 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. — View Citation

Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg. 2001 Aug;136(8):917-21. — View 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. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. — View 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 cancer†. Eur J Cardiothorac Surg. 2016 Apr;49(4):1063-7. doi: 10.1093/ejcts/ezv296. Epub 2015 Aug 30. — View 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. Review. — View Citation

Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of functional rehabilitation	Investigators will calculate preperative Activity Counts per day as a baseline then being compared to postoperative Activity Counts per day until one day when both Counts is equal. Length of functional rehabilitation defines that duration from surgical day to the day when both Counts is equal.	Through study completion, minimum 7 days
Secondary	Quality of recovery	The translation of the Danish version of the postoperative quality of recovery scale QoR-15D is used to evaluate the quality of care.	Through study completion, an average of 14 days
Secondary	The quantization of fatigue	The Christensen Fatigue Scale (ChrFS) will be utilized to evaluate the degree of fatigue.	Through study completion, an average of 14 days
Secondary	The quantization of pain	The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain.	Through study completion, an average of 14 days
Secondary	The quantization of vomiting.	The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative vomiting.	Through study completion, an average of 14 days
Secondary	The quantization of nausea.	The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative nausea.	Through study completion, an average of 14 days
Secondary	The quantization of Activity Counts	Investigators will use Electric Devices to record Activity Counts per day. Activity counts will be classified as sedentary behavior (SB) < 1303 counts/min (cpm), low intensity physical activity (LIPA) 1303 cpm - < 2588 cpm, and moderate to vigorous physical activity (MVPA) ?2588 cpm.	Through study completion, an average of 14 days
Secondary	Length of sleep time	Investigators will use devices to record the specific sleep time for patients.	Through study completion, an average of 14 days
Secondary	The quantization of morbidity	The Clavien-Dindo Classification (CDC) is applied as a standard to grade the morbidity in 30 days after surgery.	up to 30 days
Secondary	The quantization of mortality	Investigators will investigate whether patients will experience unexpected death in 30 days after surgery	up to 30 days