Early Oral Feeding After Total Gastrectomy for Cancer

NCT ID: NCT01962519

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Adenocarcinoma of the Stomach

Keywords

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gastrectomy gastric cancer oral feeding complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Early oral feeding

Early oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3

Group Type EXPERIMENTAL

Early oral feeding

Intervention Type DIETARY_SUPPLEMENT

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

Delayed oral feeding

Delayed oral feeding starting with liquids on postoperative day (POD) 4, followed by a soft diet on POD 5, and solid foods on day 6

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Marek Sierzega

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Kulig, prof.

Role: STUDY_CHAIR

First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland

Locations

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First Department of Surgery, Jagiellonian University Medical College

Krakow, Malopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marek Sierzega, MD, PhD

Role: CONTACT

Phone: +48 124248007

Email: [email protected]

Facility Contacts

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Marek Sierzega, MD, PhD

Role: primary

Other Identifiers

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K/ZDS/002306

Identifier Type: OTHER

Identifier Source: secondary_id

K/ZDS/002306

Identifier Type: -

Identifier Source: org_study_id