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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early Oral Nutrition After Total Gastrectomy
- Sponsor
- Hospital Universitari de Bellvitge
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Hospital stay
- Last Updated
- 5 years ago
Overview
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.
Investigators
Leandre Farran Teixidor
Chief of oesophagogastric surgery department
Hospital Universitari de Bellvitge
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.
Outcomes
Primary Outcomes
Hospital stay
Time Frame: postoperative 1 day to discharge, up to 1 month after surgery
Postoperatory hospital stay in days
Secondary Outcomes
- Mortality(During the admission, two weeks and one month after surgery)
- Postoperative Hemoperitoneum(postoperative 1 day to discharge, up to 1 month after surgery)
- Hospital readmissions(Two weeks and one month after surgery)
- Weight(First day of hospital admission, two weeks and one month after surgery)
- Anastomotic dehiscence(postoperative 1 day to discharge, up to 1 month after surgery)
- Duodenal stump leak(postoperative 1 day to discharge, up to 1 month after surgery)
- Paralytic ileus(postoperative 1 day to discharge, up to 1 month after surgery)
- Intra-Abdominal abscesses(postoperative 1 day to discharge, up to 1 month after surgery)
- Superficial Incisional Surgical Site Infection(postoperative 1 day to discharge, up to 1 month after surgery)
- Percentage of weight lost(First day of hospital admission, two weeks and one month after surgery)
- Evisceration(postoperative 1 day to discharge, up to 1 month after surgery)
- Height(First day of hospital admission, two weeks and one month after surgery)
- Impedancemetry(First day of hospital admission, two weeks and one month after surgery)