- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07713888
Prehabilitation for Upper Gastrointestinal Tract Cancer Surgery
The Effects of Multimodal Prehabilitation on Post-operative Recovery in Patients Undergoing Surgery for Upper Gastrointestinal Tract Cancer in Taiwan
Patients receiving surgery of upper gastrointestinal tract are often elderly, frail, malnourished, with poor functional reserve. They are associated with poor post-operative outcomes.
This multimodal treatment is associated with considerable morbidity and decline of patients' functional capacity due to sarcopenia and malnutrition. The poor outcomes can lead to a prolonged delayed recovery, hospital stay, and disability. The post-operative morbidity, especially cardiopulmonary complications, remains substantial. Prehabilitation before surgery can improve the functional capacity of patients to better withstand the stress of surgery.
In this perspective, prehabilitation has gained increasing popularity as it consists of various interventions that aim to optimize patient's preoperative condition. The rehabilitation programmes varies considerably. To maximise the benefits that can be accrued in the pre-operative period, prehabilitation programmes should be multimodal, including exercise and nutritional support. Increasing the maximal aerobic capacity by training before surgery, improves patients' functional capacity and should allow patients to better withstand the postoperative stress response.
Prehabilitation has been trialled in a range of surgical specialities, including colorectal, breast, hepatobiliary, bariatric, urological, thoracic, and orthopaedic surgery. In major abdominal surgery, multiple studies have indicated that prehabilitation improved preoperative functional capacity and postoperative outcomes. There is a large body of evidence for prehabilitation in patients undergoing intra-abdominal surgery, with studies reporting improvements in pre-operative cardiopulmonary fitness, and reductions in post-operative complications.
The data on prehabilitation after surgery for upper gastrointestinal tract are scarce and ambiguous and these studies often lacked a multimodal approach. The evidence of prehabilitation in Taiwan is scarce also. Surgery for upper gastrointestinal tract has a high morbidity and is associated with a prolonged recovery so there is significant potential to improve outcomes in this high-risk population. However, there are few studies of prehabilitation in surgery for upper gastrointestinal tract.
Hence, this study aimed to investigate the effect of a multimodal personalised, prehabilitation program on postoperative recovery and morbidity in patients undergoing surgery for upper gastrointestinal tract.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chi-Wen Lin
- Phone Number: 3980 886+0436060666
- Email: d04428006@ntu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan
- Taichung Tzu Chi Hospital
-
Contact:
- Chi-Wen Lin
- Phone Number: 3980 886+0436060666
- Email: d04428006@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged ≥ 18 years
- with a diagnosis of potentially resectable upper gastrointestinal tract cancer
Exclusion Criteria:
- inability to give informed consent
- non resectable disease
- patients who declined surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prehabilitation
|
A personalised, home-based exercise programme was prescribed by a physical therapist.
In keeping with WHO guidelines, patients were prescribed a minimum of 600 MET minutes week-1, which equates to 150 min of moderate intensity activity, with the aim of increasing this to 1200 MET minutes week-1 (300 min of moderate intensity activity).
Patients were prescribed a mixture of aerobic and strength exercises, each with a defined frequency, intensity, and duration.
Patients received training on how to undertake the exercises and how to selfregulate the intensity using the Borg scale rating of perceived exertion (RPE), with a target range of 13 to 15 depending on the patient's medical history and type of exercise.
A specialist dietitian undertook an assessment of nutritional status including identification and stratification of nutritional risk.
A plan was agreed based on symptoms, dietary eating habits, and nutritional deficiencies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital stay
Time Frame: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
|
30-day readmission rate
Time Frame: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
|
Pulmonary complications
Time Frame: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
|
Anastomotic leakage rate
Time Frame: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
|
Severity (Clavien-Dindo) of complications
Time Frame: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
- Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.
- Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30.
- Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017 Mar;39:156-162. doi: 10.1016/j.ijsu.2017.01.111. Epub 2017 Feb 2.
- Minnella EM, Bousquet-Dion G, Awasthi R, Scheede-Bergdahl C, Carli F. Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Acta Oncol. 2017 Feb;56(2):295-300. doi: 10.1080/0284186X.2016.1268268. Epub 2017 Jan 12.
- Low DE, Kuppusamy MK, Alderson D, Cecconello I, Chang AC, Darling G, Davies A, D'Journo XB, Gisbertz SS, Griffin SM, Hardwick R, Hoelscher A, Hofstetter W, Jobe B, Kitagawa Y, Law S, Mariette C, Maynard N, Morse CR, Nafteux P, Pera M, Pramesh CS, Puig S, Reynolds JV, Schroeder W, Smithers M, Wijnhoven BPL. Benchmarking Complications Associated with Esophagectomy. Ann Surg. 2019 Feb;269(2):291-298. doi: 10.1097/SLA.0000000000002611.
- Wynter-Blyth V, Moorthy K. Prehabilitation: preparing patients for surgery. BMJ. 2017 Aug 8;358:j3702. doi: 10.1136/bmj.j3702. No abstract available.
- Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
- West MA, Loughney L, Lythgoe D, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional pilot study. Br J Anaesth. 2015 Feb;114(2):244-51. doi: 10.1093/bja/aeu318. Epub 2014 Oct 1.
- Hughes MJ, Hackney RJ, Lamb PJ, Wigmore SJ, Christopher Deans DA, Skipworth RJE. Prehabilitation Before Major Abdominal Surgery: A Systematic Review and Meta-analysis. World J Surg. 2019 Jul;43(7):1661-1668. doi: 10.1007/s00268-019-04950-y.
- Moran J, Guinan E, McCormick P, Larkin J, Mockler D, Hussey J, Moriarty J, Wilson F. The ability of prehabilitation to influence postoperative outcome after intra-abdominal operation: A systematic review and meta-analysis. Surgery. 2016 Nov;160(5):1189-1201. doi: 10.1016/j.surg.2016.05.014. Epub 2016 Jul 8.
- Dewberry LC, Wingrove LJ, Marsh MD, Glode AE, Schefter TE, Leong S, Purcell WT, McCarter MD. Pilot Prehabilitation Program for Patients With Esophageal Cancer During Neoadjuvant Therapy and Surgery. J Surg Res. 2019 Mar;235:66-72. doi: 10.1016/j.jss.2018.09.060. Epub 2018 Oct 23.
- Akkerman RD, Haverkamp L, van Rossum PS, van Hillegersberg R, Ruurda JP. Long-term quality of life after oesophagectomy with gastric conduit interposition for cancer. Eur J Cancer. 2015 Aug;51(12):1538-45. doi: 10.1016/j.ejca.2015.05.006. Epub 2015 May 29.
- Bolger JC, Loughney L, Tully R, Cunningham M, Keogh S, McCaffrey N, Hickey W, Robb WB. Perioperative prehabilitation and rehabilitation in esophagogastric malignancies: a systematic review. Dis Esophagus. 2019 Nov 13;32(9):doz058. doi: 10.1093/dote/doz058.
- Zylstra J, Boshier P, Whyte GP, Low DE, Davies AR. Peri-operative patient optimization for oesophageal cancer surgery - From prehabilitation to enhanced recovery. Best Pract Res Clin Gastroenterol. 2018 Oct-Dec;36-37:61-73. doi: 10.1016/j.bpg.2018.11.006. Epub 2018 Nov 30. No abstract available.
- Piraux E, Caty G, Reychler G. Effects of preoperative combined aerobic and resistance exercise training in cancer patients undergoing tumour resection surgery: A systematic review of randomised trials. Surg Oncol. 2018 Sep;27(3):584-594. doi: 10.1016/j.suronc.2018.07.007. Epub 2018 Jul 17.
- Levett DZ, Edwards M, Grocott M, Mythen M. Preparing the patient for surgery to improve outcomes. Best Pract Res Clin Anaesthesiol. 2016 Jun;30(2):145-57. doi: 10.1016/j.bpa.2016.04.002. Epub 2016 Apr 27.
- Fransen LFC, Janssen THJB, Aarnoudse M, Nieuwenhuijzen GAP, Luyer MDP. Direct Oral Feeding After a Minimally Invasive Esophagectomy: A Single-Center Prospective Cohort Study. Ann Surg. 2022 May 1;275(5):919-923. doi: 10.1097/SLA.0000000000004036. Epub 2020 Jun 11.
- Fransen LFC, Luyer MDP. Effects of improving outcomes after esophagectomy on the short- and long-term: a review of literature. J Thorac Dis. 2019 Apr;11(Suppl 5):S845-S850. doi: 10.21037/jtd.2018.12.09.
- Rutegard M, Lagergren P, Rouvelas I, Mason R, Lagergren J. Surgical complications and long-term survival after esophagectomy for cancer in a nationwide Swedish cohort study. Eur J Surg Oncol. 2012 Jul;38(7):555-61. doi: 10.1016/j.ejso.2012.02.177. Epub 2012 Apr 6.
- Halliday LJ, Doganay E, Wynter-Blyth VA, Hanna GB, Moorthy K. The Impact of Prehabilitation on Post-operative Outcomes in Oesophageal Cancer Surgery: a Propensity Score Matched Comparison. J Gastrointest Surg. 2021 Nov;25(11):2733-2741. doi: 10.1007/s11605-020-04881-3. Epub 2020 Dec 2.
- Vermillion SA, James A, Dorrell RD, Brubaker P, Mihalko SL, Hill AR, Clark CJ. Preoperative exercise therapy for gastrointestinal cancer patients: a systematic review. Syst Rev. 2018 Jul 24;7(1):103. doi: 10.1186/s13643-018-0771-0.
- Allum WH, Griffin SM, Watson A, Colin-Jones D; Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland; British Society of Gastroenterology; British Association of Surgical Oncology. Guidelines for the management of oesophageal and gastric cancer. Gut. 2002 Jun;50 Suppl 5(Suppl 5):v1-23. doi: 10.1136/gut.50.90005.v1. No abstract available.
- Doorakkers E, Konings P, Mattsson F, Lagergren J, Brusselaers N. Early complications following oesophagectomy for cancer in relation to long-term healthcare utilisation: a prospective population-based cohort study. PLoS One. 2015 Mar 13;10(3):e0121080. doi: 10.1371/journal.pone.0121080. eCollection 2015.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTCH2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.