Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)
NCT ID: NCT03257280
Last Updated: 2021-02-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
84 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-20
Study Completion Date
2023-09-30
Brief Summary
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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.
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Detailed Description
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The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In our center, the postoperative management consisted in 1 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 progressive oral diet is begin.
In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was introduced in the surgical patients attempting to improve their postoperative course. This new concept includes the preoperative advices related to the surgery, the intensive mobilization after surgery, the early oral diet, and to avoid the routinary use of the nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is still no good evidence to sport these practice.
Based on the reasons exposed before, the investigators design a prospective randomized controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and if no evidence of drainage leakage the participants will be randomized into two groups: one of them with our classical postoperative management, and the other one implements an early oral nutrition protocol, having in considerations its effectiveness, security, and impact on the hospital stay.
In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was introduced in the surgical patients attempting to improve their postoperative course. This new concept includes the preoperative advices related to the surgery, the intensive mobilization after surgery, the early oral diet, and to avoid the routinary use of the nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is still no good evidence to sport these practice.
Based on the reasons exposed before, the investigators design a prospective randomized controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and if no evidence of drainage leakage the participants will be randomized into two groups: one of them with our classical postoperative management, and the other one implements an early oral nutrition protocol, having in considerations its effectiveness, security, and impact on the hospital stay.
Conditions
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Early Oral Nutrition After Total Gastrectomy
Gastric Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Early oral nutrition
An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
Group Type
EXPERIMENTAL
Early oral nutrition
Intervention Type
OTHER
An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
control group
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Early oral nutrition
An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* All patients requiring radical total gastrectomy for gastric cancer.
* 18 or above years old.
* Acceptance and signing the full informed consent.
* 18 or above years old.
* Acceptance and signing the full informed consent.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Sponsor Role
lead
Responsible Party
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Leandre Farran Teixidor
Chief of oesophagogastric surgery department
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Leandre Farran Teixidor, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Bellvitge University Hospital
Locations
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Leandre Farran Teixidor
L'Hospitalet de Llobregat, Barcelona, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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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.
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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.
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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.
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BACKGROUND
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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.
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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.
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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.
Reference Type
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.
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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.
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BACKGROUND
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BACKGROUND
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Reference Type
BACKGROUND
Other Identifiers
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DOPGT_2015
Identifier Type: -
Identifier Source: org_study_id
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