Adenocarcinoma of the StomachNCT01962519
Early Oral Feeding After Total Gastrectomy for Cancer
A study testing Early oral feeding in people with Adenocarcinoma of the Stomach, run by Jagiellonian University at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma of the Stomach
- What is being tested?
- Early oral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total gastrectomy for cancer
- Age 18 - 80 years
- Informed consent
Who cannot join
- Numerous hepatic and peritoneal metastases
- Extended resections (pancreas, colon)
- Preoperative malnutrition requiring total parenteral nutrition
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
First Department of Surgery, Jagiellonian University Medical College
Krakow, Malopolska, 31-501
Marek Sierzega, MD, PhD, +48 124248007, marek.sierzega@uj.edu.pl
Jan Kulig, Prof.
About this study
Official title: A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer
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).
- Conditions
- Adenocarcinoma of the Stomach
- Being tested
- Early oral feeding
- Keywords
- gastrectomy, gastric cancer, oral feeding, complications
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral feedingDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Early oral feeding | Experimental | 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 Receives: Dietary Supplement: Early oral feeding |
| Delayed oral feeding | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay
Time between surgery and patient discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary outcomes (1)
Morbidity
Any complication occurring during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Sierzega, Jagiellonian University
- Investigators
- Jan Kulig, prof., Study chair, First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962519
- Sponsor's protocol ID
- K/ZDS/002306
- Other IDs
- K/ZDS/002306
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer
- ClinicalTrials.gov ID
- NCT01962519
- Acronym / sponsor ID
- K/ZDS/002306
- Conditions
- Adenocarcinoma of the Stomach
- Keywords
- gastrectomy, gastric cancer, oral feeding, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding | Experimental | Dietary Supplement: Early oral feedingEarly oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3 |
| Delayed oral feeding | No intervention | –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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total gastrectomy for cancer
- Age 18 - 80 years
- Informed consent
Key exclusion criteria (4 listed)
- Numerous hepatic and peritoneal metastases
- Extended resections (pancreas, colon)
- Preoperative malnutrition requiring total parenteral nutrition
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early oral feedingOral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter | Dietary supplement | Early oral feeding |
Primary outcome
Postoperative hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Time between surgery and patient discharge
1 secondary outcome
Morbidity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kulig, prof. study chair
First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral feeding in people with Adenocarcinoma of the Stomach, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Sierzega, MD, PhD (+48 124248007, marek.sierzega@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hospital stay (time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.