Frailty and Postoperative Outcomes After Gastric Cancer Surgery

NCT03568110 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Gastric cancer is an important health care problem even though treatment advances, and it is diagnosed mainly in elderly. Surgery is the main treatment for gastric cancer and is associated with a high rate of postoperative complications and mortality, even higher in older patients. Chronological age seems not to be the main factor influencing the worse outcome of older patients, comorbidities and frailty have also been taken into account recently. Methods. Participation in the study will be offered to all centers that are currently part of the Spanish EURECCA (EUropean REgistry of Cancer CAre) Esophagogastric Cancer Registry. The impact of the frailty on different outcome variables will be evaluated. The main outcome variable will be 90-day mortality after the intervention. Health-Related Quality of Life (HRQoL) will also be evaluated. Objective. The objective of the study is to value the impact of frailty on gastric cancer surgery outcomes therein the Spanish EURECCA Esophagogastric Cancer Registry.

Conditions

Gastric Cancer; Frail Elderly Syndrome; Postoperative Complications; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  Mortality at 90 days after surgery

  90 days after surgery

Secondary Outcomes (11)

• Severe complications

  30 days after surgery

• Complication Comprehensive Index

  30 days after surgery

• Failure to rescue

  30 days after surgery

• Hospital stay

  30 days after surgery

• Patient discharge facility

  30 days after surgery

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The possibility to participate to the study will be offered to all the hospitals members of the Spanish EURECCA Esophagogastric Cancer Registry. The hospitals that will participate must sign a commitment. Every patient that fit the eligibility criteria will be part of the study.

You may qualify if:

• ≥ 70 years patients diagnosed with gastric cancer candidates for radical resection

You may not qualify if:

• metastatic patients
• patients candidates for palliative treatment
• patients without a signed informed consent

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

H. U. Germans Trias i Pujol

Badalona, Spain

Location

Related Publications (36)

• Hamilton TD, Mahar AL, Haas B, Beyfuss K, Law CHL, Karanicolas PJ, Coburn NG, Hallet J. The impact of advanced age on short-term outcomes following gastric cancer resection: an ACS-NSQIP analysis. Gastric Cancer. 2018 Jul;21(4):710-719. doi: 10.1007/s10120-017-0786-6. Epub 2017 Dec 11.

  PMID: 29230588 BACKGROUND

• Polanczyk CA, Marcantonio E, Goldman L, Rohde LE, Orav J, Mangione CM, Lee TH. Impact of age on perioperative complications and length of stay in patients undergoing noncardiac surgery. Ann Intern Med. 2001 Apr 17;134(8):637-43. doi: 10.7326/0003-4819-134-8-200104170-00008.

  PMID: 11304103 BACKGROUND

• Kim SW, Han HS, Jung HW, Kim KI, Hwang DW, Kang SB, Kim CH. Multidimensional frailty score for the prediction of postoperative mortality risk. JAMA Surg. 2014 Jul;149(7):633-40. doi: 10.1001/jamasurg.2014.241.

  PMID: 24804971 BACKGROUND

• Tegels JJ, Stoot JH. Way forward: Geriatric frailty assessment as risk predictor in gastric cancer surgery. World J Gastrointest Surg. 2015 Oct 27;7(10):223-5. doi: 10.4240/wjgs.v7.i10.223.

  PMID: 26523209 BACKGROUND

• Partridge JS, Harari D, Dhesi JK. Frailty in the older surgical patient: a review. Age Ageing. 2012 Mar;41(2):142-7. doi: 10.1093/ageing/afr182.

  PMID: 22345294 BACKGROUND

• Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

  PMID: 23764209 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.

  PMID: 17634318 BACKGROUND

• McIsaac DI, Bryson GL, van Walraven C. Association of Frailty and 1-Year Postoperative Mortality Following Major Elective Noncardiac Surgery: A Population-Based Cohort Study. JAMA Surg. 2016 Jun 1;151(6):538-45. doi: 10.1001/jamasurg.2015.5085.

  PMID: 26791334 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Velanovich V, Antoine H, Swartz A, Peters D, Rubinfeld I. Accumulating deficits model of frailty and postoperative mortality and morbidity: its application to a national database. J Surg Res. 2013 Jul;183(1):104-10. doi: 10.1016/j.jss.2013.01.021. Epub 2013 Feb 1.

  PMID: 23415494 BACKGROUND

• Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.

  PMID: 22250183 BACKGROUND

• Smets IH, Kempen GI, Janssen-Heijnen ML, Deckx L, Buntinx FJ, van den Akker M. Four screening instruments for frailty in older patients with and without cancer: a diagnostic study. BMC Geriatr. 2014 Feb 26;14:26. doi: 10.1186/1471-2318-14-26.

  PMID: 24571290 BACKGROUND

• Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6.

  PMID: 22881367 BACKGROUND

• Robinson TN, Wu DS, Pointer L, Dunn CL, Cleveland JC Jr, Moss M. Simple frailty score predicts postoperative complications across surgical specialties. Am J Surg. 2013 Oct;206(4):544-50. doi: 10.1016/j.amjsurg.2013.03.012. Epub 2013 Jul 20.

  PMID: 23880071 BACKGROUND

• Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.

  PMID: 20510798 BACKGROUND

• Robinson TN, Wallace JI, Wu DS, Wiktor A, Pointer LF, Pfister SM, Sharp TJ, Buckley MJ, Moss M. Accumulated frailty characteristics predict postoperative discharge institutionalization in the geriatric patient. J Am Coll Surg. 2011 Jul;213(1):37-42; discussion 42-4. doi: 10.1016/j.jamcollsurg.2011.01.056. Epub 2011 Mar 23.

  PMID: 21435921 BACKGROUND

• Hall DE, Arya S, Schmid KK, Carlson MA, Lavedan P, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning JM. Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days. JAMA Surg. 2017 Mar 1;152(3):233-240. doi: 10.1001/jamasurg.2016.4219.

  PMID: 27902826 BACKGROUND

• Fagard K, Leonard S, Deschodt M, Devriendt E, Wolthuis A, Prenen H, Flamaing J, Milisen K, Wildiers H, Kenis C. The impact of frailty on postoperative outcomes in individuals aged 65 and over undergoing elective surgery for colorectal cancer: A systematic review. J Geriatr Oncol. 2016 Nov;7(6):479-491. doi: 10.1016/j.jgo.2016.06.001. Epub 2016 Jun 21.

  PMID: 27338516 BACKGROUND

• Mosquera C, Spaniolas K, Fitzgerald TL. Impact of frailty on surgical outcomes: The right patient for the right procedure. Surgery. 2016 Aug;160(2):272-80. doi: 10.1016/j.surg.2016.04.030. Epub 2016 Jun 3.

  PMID: 27267548 BACKGROUND

• Tegels JJ, de Maat MF, Hulsewe KW, Hoofwijk AG, Stoot JH. Value of geriatric frailty and nutritional status assessment in predicting postoperative mortality in gastric cancer surgery. J Gastrointest Surg. 2014 Mar;18(3):439-45; discussion 445-6. doi: 10.1007/s11605-013-2443-7. Epub 2014 Jan 14.

  PMID: 24420730 BACKGROUND

• Augustin T, Burstein MD, Schneider EB, Morris-Stiff G, Wey J, Chalikonda S, Walsh RM. Frailty predicts risk of life-threatening complications and mortality after pancreatic resections. Surgery. 2016 Oct;160(4):987-996. doi: 10.1016/j.surg.2016.07.010. Epub 2016 Aug 18.

  PMID: 27545992 BACKGROUND

• Vermillion SA, Hsu FC, Dorrell RD, Shen P, Clark CJ. Modified frailty index predicts postoperative outcomes in older gastrointestinal cancer patients. J Surg Oncol. 2017 Jun;115(8):997-1003. doi: 10.1002/jso.24617. Epub 2017 Apr 24.

  PMID: 28437582 BACKGROUND

• Hewitt J, Moug SJ, Middleton M, Chakrabarti M, Stechman MJ, McCarthy K; Older Persons Surgical Outcomes Collaboration. Prevalence of frailty and its association with mortality in general surgery. Am J Surg. 2015 Feb;209(2):254-9. doi: 10.1016/j.amjsurg.2014.05.022. Epub 2014 Jul 27.

  PMID: 25173599 BACKGROUND

• Obeid NM, Azuh O, Reddy S, Webb S, Reickert C, Velanovich V, Horst HM, Rubinfeld I. Predictors of critical care-related complications in colectomy patients using the National Surgical Quality Improvement Program: exploring frailty and aggressive laparoscopic approaches. J Trauma Acute Care Surg. 2012 Apr;72(4):878-83. doi: 10.1097/TA.0b013e31824d0f70.

  PMID: 22491599 BACKGROUND

• Abdullah HR, Lien VP, Ong HK, Er PL, Hao Y, Khan SA, Liu CW. Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery. BMJ Open. 2017 Aug 4;7(8):e016815. doi: 10.1136/bmjopen-2017-016815.

  PMID: 28778994 BACKGROUND

• Huddleston JM, Long KH, Naessens JM, Vanness D, Larson D, Trousdale R, Plevak M, Cabanela M, Ilstrup D, Wachter RM; Hospitalist-Orthopedic Team Trial Investigators. Medical and surgical comanagement after elective hip and knee arthroplasty: a randomized, controlled trial. Ann Intern Med. 2004 Jul 6;141(1):28-38. doi: 10.7326/0003-4819-141-1-200407060-00012.

  PMID: 15238368 BACKGROUND

• Macpherson DS, Lofgren RP. Outpatient internal medicine preoperative evaluation: a randomized clinical trial. Med Care. 1994 May;32(5):498-507. doi: 10.1097/00005650-199405000-00008.

  PMID: 8182977 BACKGROUND

• Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.

  PMID: 24303856 BACKGROUND

• Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

  PMID: 23052535 BACKGROUND

• Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD010118. doi: 10.1002/14651858.CD010118.pub2.

  PMID: 23152283 BACKGROUND

• Baitar A, Van Fraeyenhove F, Vandebroek A, De Droogh E, Galdermans D, Mebis J, Schrijvers D. Evaluation of the Groningen Frailty Indicator and the G8 questionnaire as screening tools for frailty in older patients with cancer. J Geriatr Oncol. 2013 Jan;4(1):32-8. doi: 10.1016/j.jgo.2012.08.001. Epub 2012 Aug 24.

  PMID: 24071490 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

  PMID: 25379846 BACKGROUND

• Schwarz R, Hinz A. Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population. Eur J Cancer. 2001 Jul;37(11):1345-51. doi: 10.1016/s0959-8049(00)00447-0.

  PMID: 11435063 BACKGROUND

• Avery K, Hughes R, McNair A, Alderson D, Barham P, Blazeby J. Health-related quality of life and survival in the 2 years after surgery for gastric cancer. Eur J Surg Oncol. 2010 Feb;36(2):148-54. doi: 10.1016/j.ejso.2009.09.008.

  PMID: 19836921 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Pera

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Head of Section of Gastrointestinal Surgery

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 26, 2018
• Study Start: March 5, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

ES (1)