Early Oral Feeding After Total Gastrectomy for Cancer

Adenocarcinoma of the Stomach Clinical Trial

Official title:

A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962519
• Other study ID #: K/ZDS/002306
• Secondary ID: K/ZDS/002306
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2013
• Last updated: October 10, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Jagiellonian University
• Contact: Marek Sierzega, MD, PhD
• Phone: +48 124248007
• Email: marek.sierzega[@]uj.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Total gastrectomy for cancer

• Age 18 - 80 years

• Informed consent

Exclusion Criteria:

• Numerous hepatic and peritoneal metastases

• Extended resections (pancreas, colon)

• Preoperative malnutrition requiring total parenteral nutrition

• Emergency surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Stomach

Intervention

Dietary Supplement:
• Early oral feeding
Oral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter

Locations

Country	Name	City	State
Poland	First Department of Surgery, Jagiellonian University Medical College	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-admissions	Hospital readmissions within 30 days after discharge	30 days after discharge	Yes
Other	Effective oral feeding	Time to reach oral feeding covering 75% of patient's requirements	Participants will be followed for the duration of hospital stay, an expected average of 8 days	No
Other	Quality of life	Quality of life measured by EORTC QLQ-C30 and EORTC QLQ - STO22	Preoperatively, postoperative day 7, 14 days after discharge	No
Other	Laboratory parameters	Laboratory tests, including lymphocyte count, blood albumin, blood prealbumin	Preoperatively, postoperative day 1 and 8	No
Primary	Postoperative hospital stay	Time between surgery and patient discharge	Participants will be followed for the duration of hospital stay, an expected average of 8 days	No
Secondary	Morbidity	Any complication occurring during hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 8 days	Yes