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

Hospital Universitari de Bellvitge84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Early Oral Nutrition After Total Gastrectomy Gastric Cancer

Interventions

Early oral nutritionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Leandre Farran Teixidor

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Hospital stay

Postoperatory hospital stay in days

Time frame: postoperative 1 day to discharge, up to 1 month after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: Two weeks and one month after surgery

Weight

weight shall be measured in kilograms

Time frame: 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

Time frame: 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.

Central 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

Data from ClinicalTrials.gov

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