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

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.

Early oral nutrition

Leandre Farran Teixidor, PhD, MD

Fernando Estremiana Garcia, MD

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.

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.

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

Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Gastric Cancer Patients After Total Gastrectomy: A Prospective Randomized Control Trial (DOPGT_2015)

Postoperative Mortality: Deaths occurring during admission and / or within 30 days after surgery or during surgical admission if it lasts longer than 30 days.

It will be considered the income produced within 30 days after the surgical intervention in which the cause of the admission is attributed to a complication in relation to the surgical intervention.

Anastomotic dehiscence: If the intra-abdominal drainage presents a purulent appearance or an amylase determination\> 30, suspicion of anastomosis dehiscence will be made; In this situation, a clinical test (intake of methylene blue) radiological test (with oral contrast) or endoscopy will be requested to confirm the diagnosis. Anastomosis dehiscence will be confirmed if any of the following occurs:

* Exit of methylene blue through intra-abdominal drainage
* Contrast leakage in a radiological test performed for sepsis
* Evidence of dehiscence in a fibrogastroscopy
* Evidence of anastomotic dehiscence during a reintervention

Intra-abdominal drainage presents a purulent appearance with amylase determination\> 30 and a bilirubin value higher than plasmatic bilirubin.

When three of the following criteria are met.

Oral intolerance after the fourth postoperative day Abdominal distention and tympanism No bowel motions or flatus Compatible abdominal x-ray

1. Radiological criteria:

   Air inside the collection Collection with heterogeneous and irregular pickup or wall pickup Collection with heterogeneous content
2. Isolation of one or more microorganisms in culture after percutaneous collection

Presence of blood in the abdominal cavity after gastrectomy that needs any kind of treatments

Extrusion of viscera outside the body through a surgical incision

Superficial Incisional Surgical Site Infection

Infection within 30 days after the operation and only involves skin and subcutaneous tissue of the incision and at least one of the following:

Purulent drainage with or without laboratory confirmation, from the superficial incision.

Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.

At least one of the following signs or symptoms of infection: pain or tenderness, localised swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.

Diagnosis of superficial incisional surgical site infection made by a surgeon or attending physician.

Percentage of weight lost shall be measured in percentage

The impedanciometry will record:

Phase-angle Na / K ratio Basal metabolism (Kcal) Fat mass percentage Muscle mass percentage Cell mass percentage Extracellular mass percentage

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)	NCT03257280	Early Oral Nutr... Gastric Cancer	Early oral nutr...	18 Years -	Hospital Universitari de Bellvitge
Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)	NCT03257280	Early Oral Nutr... Gastric Cancer	Early oral nutr...	18 Years -	Hospital Universitari de Bellvitge

Spots Global Cancer Trial Database for early oral nutrition after total gastrectomy