Clinical trial NCT03257280: Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Oral Nutrition After Total Gastrectomy
Gastric Cancer
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital stay
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
Secondary outcomes:
measure: Mortality
timeFrame: During the admission, two weeks and one month after surgery
measure: Hospital readmissions
timeFrame: Two weeks and one month after surgery
measure: Weight
timeFrame: First day of hospital admission, two weeks and one month after surgery
measure: Anastomotic dehiscence
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Duodenal stump leak
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Paralytic ileus
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Intra-Abdominal abscesses
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Postoperative Hemoperitoneum
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Evisceration
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Superficial Incisional Surgical Site Infection
timeFrame: postoperative 1 day to discharge, up to 1 month after surgery
measure: Height
timeFrame: First day of hospital admission, two weeks and one month after surgery
measure: Percentage of weight lost
timeFrame: First day of hospital admission, two weeks and one month after surgery
measure: Impedancemetry
timeFrame: First day of hospital admission, two weeks and one month after surgery
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Leandre Farran Teixidor
state: Barcelona
Study officials:
affiliation: Bellvitge University Hospital
name: Leandre Farran Teixidor, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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