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

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Early Oral Nutrition After Total Gastrectomy, Gastric Cancer

Intervention / Treatment
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* Other: Early oral nutrition


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oral nutrition<br>An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy. | Other: Early oral nutrition<br>* An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Postoperatory hospital stay in days | postoperative 1 day to discharge, up to 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Postoperative Mortality: Deaths occurring during admission and / or within 30 days after surgery or during surgical admission if it lasts longer than 30 days. | During the admission, two weeks and one month after surgery | 
| Hospital readmissions | 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. | Two weeks and one month after surgery | 
| Weight | weight shall be measured in kilograms | First day of hospital admission, two weeks and one month after surgery | 
| Anastomotic dehiscence | 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 | postoperative 1 day to discharge, up to 1 month after surgery | 
| Duodenal stump leak | Intra-abdominal drainage presents a purulent appearance with amylase determination> 30 and a bilirubin value higher than plasmatic bilirubin. | postoperative 1 day to discharge, up to 1 month after surgery | 
| Paralytic ileus | 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 | postoperative 1 day to discharge, up to 1 month after surgery | 
| Intra-Abdominal abscesses | Radiological criteria: Air inside the collection Collection with heterogeneous and irregular pickup or wall pickup Collection with heterogeneous content Isolation of one or more microorganisms in culture after percutaneous collection | postoperative 1 day to discharge, up to 1 month after surgery | 
| Postoperative Hemoperitoneum | Presence of blood in the abdominal cavity after gastrectomy that needs any kind of treatments | postoperative 1 day to discharge, up to 1 month after surgery | 
| Evisceration | Extrusion of viscera outside the body through a surgical incision | postoperative 1 day to discharge, up to 1 month after surgery | 
| Superficial Incisional Surgical Site Infection | 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. | postoperative 1 day to discharge, up to 1 month after surgery | 
| Height | Height shall be measured in meters | First day of hospital admission, two weeks and one month after surgery | 
| Percentage of weight lost | Percentage of weight lost shall be measured in percentage | First day of hospital admission, two weeks and one month after surgery | 
| Impedancemetry | The impedanciometry will record: Phase-angle Na / K ratio Basal metabolism (Kcal) Fat mass percentage Muscle mass percentage Cell mass percentage Extracellular mass percentage | First day of hospital admission, two weeks and one month after surgery |