Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)

NCT03257280 | Unknown

• 1 other identifier: DOPGT_2015
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled clinical trial to clarify the effect of early oral nutrition introduction after total gastrectomy in gastric cancer patients on the length of hospital stay, comparing an experimental group vs control group.

Conditions

Early Oral Nutrition After Total Gastrectomy; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  Postoperatory hospital stay in days

  postoperative 1 day to discharge, up to 1 month after surgery

Secondary Outcomes (13)

• Mortality

  During the admission, two weeks and one month after surgery

• Hospital readmissions

  Two weeks and one month after surgery

• Weight

  First day of hospital admission, two weeks and one month after surgery

• Anastomotic dehiscence

  postoperative 1 day to discharge, up to 1 month after surgery

• Duodenal stump leak

  postoperative 1 day to discharge, up to 1 month after surgery

Study Arms (2)

Early oral nutrition

EXPERIMENTAL

An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.

Other: Early oral nutrition

control group

NO INTERVENTION

In our center, the classical postoperative management consisted in one week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a three days progressive oral diet is begin.

Interventions

Early oral nutrition OTHER

An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.

Early oral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring radical total gastrectomy for gastric cancer.
• or above years old.
• Acceptance and signing the full informed consent.

You may not qualify if:

• Patient with poorly controlled diabetes mellitus (glycosylated hemoglobin levels greater than 7%)
• Emergency surgery.
• Total gastrectomy with esophagus-jejunal manual suture.
• Early dehiscence of esophagus-jejunal anastomosis (first 24 hours).
• Reintervention for abdominal complication in the first 24 hours.
• Surgery involving large intestinal or colon resections.
• Proximal resection margin affected requiring a esophagectomy and reconstruction with coloplasty.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Leandre Farran Teixidor

L'Hospitalet de Llobregat, Barcelona, 08026, Spain

RECRUITING

Related Publications (36)

• Gonzalez CA, Agudo A. Carcinogenesis, prevention and early detection of gastric cancer: where we are and where we should go. Int J Cancer. 2012 Feb 15;130(4):745-53. doi: 10.1002/ijc.26430. Epub 2011 Oct 20.

  PMID: 21918974 BACKGROUND

• Allum WH, Blazeby JM, Griffin SM, Cunningham D, Jankowski JA, Wong R; Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, the British Society of Gastroenterology and the British Association of Surgical Oncology. Guidelines for the management of oesophageal and gastric cancer. Gut. 2011 Nov;60(11):1449-72. doi: 10.1136/gut.2010.228254. Epub 2011 Jun 24. No abstract available.

  PMID: 21705456 BACKGROUND

• Van Cutsem E, Dicato M, Geva R, Arber N, Bang Y, Benson A, Cervantes A, Diaz-Rubio E, Ducreux M, Glynne-Jones R, Grothey A, Haller D, Haustermans K, Kerr D, Nordlinger B, Marshall J, Minsky BD, Kang YK, Labianca R, Lordick F, Ohtsu A, Pavlidis N, Roth A, Rougier P, Schmoll HJ, Sobrero A, Tabernero J, Van de Velde C, Zalcberg J. The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010. Ann Oncol. 2011 Jun;22 Suppl 5:v1-9. doi: 10.1093/annonc/mdr284.

  PMID: 21633049 BACKGROUND

• Viudez-Berral A, Miranda-Murua C, Arias-de-la-Vega F, Hernandez-Garcia I, Artajona-Rosino A, Diaz-de-Liano A, Vera-Garcia R. Current management of gastric cancer. Rev Esp Enferm Dig. 2012 Mar;104(3):134-41. doi: 10.4321/s1130-01082012000300006.

  PMID: 22449155 BACKGROUND

• Okines A, Verheij M, Allum W, Cunningham D, Cervantes A; ESMO Guidelines Working Group. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v50-4. doi: 10.1093/annonc/mdq164. No abstract available.

  PMID: 20555102 BACKGROUND

• Wong J, Kelly KJ, Mittra A, Gonen M, Allen P, Fong Y, Coit D. Rt-PCR increases detection of submicroscopic peritoneal metastases in gastric cancer and has prognostic significance. J Gastrointest Surg. 2012 May;16(5):889-96; discussion 896. doi: 10.1007/s11605-012-1845-2. Epub 2012 Feb 24.

  PMID: 22362071 BACKGROUND

• Takata A, Kurokawa Y, Fujiwara Y, Nakamura Y, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Takiguchi S, Mori M, Doki Y. Prognostic value of CEA and CK20 mRNA in the peritoneal lavage fluid of patients undergoing curative surgery for gastric cancer. World J Surg. 2014 May;38(5):1107-11. doi: 10.1007/s00268-013-2385-y.

  PMID: 24305936 BACKGROUND

• Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.

  PMID: 20882416 BACKGROUND

• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.

  PMID: 21573742 BACKGROUND

• Feng F, Ji G, Li JP, Li XH, Shi H, Zhao ZW, Wu GS, Liu XN, Zhao QC. Fast-track surgery could improve postoperative recovery in radical total gastrectomy patients. World J Gastroenterol. 2013 Jun 21;19(23):3642-8. doi: 10.3748/wjg.v19.i23.3642.

  PMID: 23801867 BACKGROUND

• Deguchi Y, Fukagawa T, Morita S, Ohashi M, Saka M, Katai H. Identification of risk factors for esophagojejunal anastomotic leakage after gastric surgery. World J Surg. 2012 Jul;36(7):1617-22. doi: 10.1007/s00268-012-1559-3.

  PMID: 22415758 BACKGROUND

• Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Piccione F, Amicucci G. Prevention of anastomotic leakage after total gastrectomy with perioperative supplemental oxygen administration: a prospective randomized, double-blind, controlled, single-center trial. Ann Surg Oncol. 2013 May;20(5):1584-90. doi: 10.1245/s10434-012-2714-7. Epub 2012 Oct 26.

  PMID: 23099730 BACKGROUND

• Kucukay F, Okten RS, Parlak E, Disibeyaz S, Ozogul Y, Bostanci EB, Olcer T. Self-expanding covered metallic stent treatment of esophagojejunostomy fistulas. Abdom Imaging. 2013 Apr;38(2):244-8. doi: 10.1007/s00261-012-9895-1.

  PMID: 22527158 BACKGROUND

• Lang H, Piso P, Stukenborg C, Raab R, Jahne J. Management and results of proximal anastomotic leaks in a series of 1114 total gastrectomies for gastric carcinoma. Eur J Surg Oncol. 2000 Mar;26(2):168-71. doi: 10.1053/ejso.1999.0764.

  PMID: 10744938 BACKGROUND

• Langer FB, Wenzl E, Prager G, Salat A, Miholic J, Mang T, Zacherl J. Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent. Ann Thorac Surg. 2005 Feb;79(2):398-403; discussion 404. doi: 10.1016/j.athoracsur.2004.07.006.

  PMID: 15680802 BACKGROUND

• Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.

  PMID: 7891489 BACKGROUND

• Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

  PMID: 11222424 BACKGROUND

• Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.

  PMID: 12095591 BACKGROUND

• Kehlet H. Future perspectives and research initiatives in fast-track surgery. Langenbecks Arch Surg. 2006 Sep;391(5):495-8. doi: 10.1007/s00423-006-0087-8. Epub 2006 Aug 19.

  PMID: 16924532 BACKGROUND

• Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.

  PMID: 18650627 BACKGROUND

• Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.

  PMID: 16775831 BACKGROUND

• Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

  PMID: 20116145 BACKGROUND

• Kehlet H, Slim K. The future of fast-track surgery. Br J Surg. 2012 Aug;99(8):1025-6. doi: 10.1002/bjs.8832. Epub 2012 Jun 14. No abstract available.

  PMID: 22696149 BACKGROUND

• Olsen MF, Wennberg E. Fast-track concepts in major open upper abdominal and thoracoabdominal surgery: a review. World J Surg. 2011 Dec;35(12):2586-93. doi: 10.1007/s00268-011-1241-1.

  PMID: 21882022 BACKGROUND

• Lassen K, Kjaeve J, Fetveit T, Trano G, Sigurdsson HK, Horn A, Revhaug A. Allowing normal food at will after major upper gastrointestinal surgery does not increase morbidity: a randomized multicenter trial. Ann Surg. 2008 May;247(5):721-9. doi: 10.1097/SLA.0b013e31815cca68.

  PMID: 18438106 BACKGROUND

• Hur H, Si Y, Kang WK, Kim W, Jeon HM. Effects of early oral feeding on surgical outcomes and recovery after curative surgery for gastric cancer: pilot study results. World J Surg. 2009 Jul;33(7):1454-8. doi: 10.1007/s00268-009-0009-3.

  PMID: 19399550 BACKGROUND

• Lewis SJ, Andersen HK, Thomas S. Early enteral nutrition within 24 h of intestinal surgery versus later commencement of feeding: a systematic review and meta-analysis. J Gastrointest Surg. 2009 Mar;13(3):569-75. doi: 10.1007/s11605-008-0592-x. Epub 2008 Jul 16.

  PMID: 18629592 BACKGROUND

• Liu XX, Jiang ZW, Wang ZM, Li JS. Multimodal optimization of surgical care shows beneficial outcome in gastrectomy surgery. JPEN J Parenter Enteral Nutr. 2010 May-Jun;34(3):313-21. doi: 10.1177/0148607110362583.

  PMID: 20467014 BACKGROUND

• Wang D, Kong Y, Zhong B, Zhou X, Zhou Y. Fast-track surgery improves postoperative recovery in patients with gastric cancer: a randomized comparison with conventional postoperative care. J Gastrointest Surg. 2010 Apr;14(4):620-7. doi: 10.1007/s11605-009-1139-5. Epub 2010 Jan 28.

  PMID: 20108171 BACKGROUND

• Chen Hu J, Xin Jiang L, Cai L, Tao Zheng H, Yuan Hu S, Bing Chen H, Chang Wu G, Fei Zhang Y, Chuan Lv Z. Preliminary experience of fast-track surgery combined with laparoscopy-assisted radical distal gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Oct;16(10):1830-9. doi: 10.1007/s11605-012-1969-4. Epub 2012 Aug 2.

  PMID: 22854954 BACKGROUND

• Kim JW, Kim WS, Cheong JH, Hyung WJ, Choi SH, Noh SH. Safety and efficacy of fast-track surgery in laparoscopic distal gastrectomy for gastric cancer: a randomized clinical trial. World J Surg. 2012 Dec;36(12):2879-87. doi: 10.1007/s00268-012-1741-7.

  PMID: 22941233 BACKGROUND

• Fujitani K, Tsujinaka T, Fujita J, Miyashiro I, Imamura H, Kimura Y, Kobayashi K, Kurokawa Y, Shimokawa T, Furukawa H; Osaka Gastrointestinal Cancer Chemotherapy Study Group. Prospective randomized trial of preoperative enteral immunonutrition followed by elective total gastrectomy for gastric cancer. Br J Surg. 2012 May;99(5):621-9. doi: 10.1002/bjs.8706. Epub 2012 Feb 24.

  PMID: 22367794 BACKGROUND

• Marano L, Porfidia R, Pezzella M, Grassia M, Petrillo M, Esposito G, Braccio B, Gallo P, Boccardi V, Cosenza A, Izzo G, Di Martino N. Clinical and immunological impact of early postoperative enteral immunonutrition after total gastrectomy in gastric cancer patients: a prospective randomized study. Ann Surg Oncol. 2013 Nov;20(12):3912-8. doi: 10.1245/s10434-013-3088-1. Epub 2013 Jul 10.

  PMID: 23838912 BACKGROUND

• Braga M, Gianotti L, Vignali A, Di Carlo V. Immunonutrition in gastric cancer surgical patients. Nutrition. 1998 Nov-Dec;14(11-12):831-5. doi: 10.1016/s0899-9007(98)00103-8.

  PMID: 9834924 BACKGROUND

• Mabvuure NT, Roman A, Khan OA. Enteral immunonutrition versus standard enteral nutrition for patients undergoing oesophagogastric resection for cancer. Int J Surg. 2013;11(2):122-7. doi: 10.1016/j.ijsu.2012.12.012. Epub 2012 Dec 26.

  PMID: 23274278 BACKGROUND

• Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.

  PMID: 25047143 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Leandre Farran Teixidor, PhD, MD

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leandre Farran Teixidor, PhD, MD

CONTACT

+34-93-335-90-11; lfarran@bellvitgehospital.cat

Fernando Estremiana Garcia, MD

CONTACT

+34-93-335-90-11; festremiana@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of oesophagogastric surgery department

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: August 22, 2017
• Study Start: October 20, 2017
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

ES (1)