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

Catalan Institute of Health

Status: Unknown

Conditions: Gastric Cancer; Early Oral Nutrition After Total Gastrectomy

Treatments: Other: Early oral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03257280

DOPGT_2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Early oral nutrition

Experimental group

Description:

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

Treatment:

Other: Early oral nutrition

control group

No Intervention group

Description:

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.