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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


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
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