FastingPhase 2NCT01642953
Early Recovery After Gastric Cancer Surgery
A Phase 2 study testing Early recovery in people with Fasting and Malignant Neoplasm of Stomach, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Study preparation To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Fasting, Malignant Neoplasm of Stomach
- What is being tested?
- Early recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Aug 2014
- Phase
- Phase 2
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are diagnosed with gastric adenocarcinoma
- 65 years old and blew
- Patients are expected to be undergone distal subtotal gastrectomy
- No complication by gastric cancer
- No synchronous metastatic lesions
- Laparoscopic or robotic surgery
- Informed consent
Who cannot join
- Previous gastrectomy history
- Combined surgery due to synchronous malignancy
- Patients with major organ dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, 443-721
Hoon Hur, prof., +82-31-219-5200, hhcmc75@naver.com
Sang-Uk Han, prof., +82-31-219-5200, hansu@ajou.ac.kr
About this study
Official title: Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
Study preparation
- To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year.
- Through this retrospective analysis, we decided the inclusion criteria which showed significantly the lower complication rate and shorter hospital stay.
Read more
Method for Prospective study
- Patients who enroll in this prospective study are administered and are supplied a liquid diet one day before surgery without bowel preparation.
- After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
Read the detailed description
Enrollment of patients
- Before the patients are enrolled in this study, they give us informed consents.
- A liquid diet is supplied beginning from the morning of the day prior to operation to the midnight.
Operation and postoperative management
- All procedures are approached by laparoscopic surgery, and partial gastrectomy with lymph node dissection are performed.
- The patients who are considered to be difficult to progress early oral feeding in surgical field are excluded from the study.
- Nasogastric tube is not applied to patients.
- Postoperative pain is managed by non-opioid pain killer.
- The patients are started on sips of water on the first postoperative day.
- If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them.
- We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
Evaluation of patients
- The patients are followed up to 30 days after discharge from hospital, and we check whether they are tolerable without any compliant and are readmitted.
- Conditions
- Fasting, Malignant Neoplasm of Stomach
- Being tested
- Early recovery
- Keywords
- Gastric cancer surgery, Early oral feeding, Fast track surgery
- Medical subject headings
- Fasting, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early recoveryDietary supplement
The patients are started on sips of water on the first postoperative day. If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them. We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
| Study group | Role | What they receive |
|---|---|---|
| Early recovery | Experimental | Patients who enroll in this arm are supplied a liquid diet one day before surgery without bowel preparation.
After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination. Receives: Dietary Supplement: Early recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop rate from critical pathway
It is defined as the proportion of dropped patients from 4 days critical pathway
Measured: 4 days
Secondary outcomes (4)
Postoperative pain
It is defined as the change of pain scale after surgery
Measured: 7 days
Postoperative complication
It is defined the complications after surgery
Measured: 30 days
Postoperative mortality
It will defined as the death case during 30 days after surgery
Measured: 30 days
Recovery after surgery
It is defined as the time to first flatus and recovery of bowel activity after surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Hoon Hur, Ajou University School of Medicine
- Investigators
- Hoon Hur, Prof., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642953
- Sponsor's protocol ID
- AJIRB-MED-MDB-12-002
- Status last verified
- Jul 2012
- First submitted
- 14 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Roh CK, Son SY, Lee SY, Hur H, Han SU. Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single-center phase II clinical trial for safety and efficacy. J Surg Oncol. 2020 Mar;121(4):662-669. doi: 10.1002/jso.25837. Epub 2020 Jan 12.
PubMed 31930513
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT01642953
- Acronym / sponsor ID
- AJIRB-MED-MDB-12-002
- Conditions
- Fasting, Malignant Neoplasm of Stomach
- Keywords
- Gastric cancer surgery, Early oral feeding, Fast track surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Jul 2012 (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.
Study preparation
- To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year.
- Through this retrospective analysis, we decided the inclusion criteria which showed significantly the lower complication rate and shorter hospital stay.
Method for Prospective study
- Patients who enroll in this prospective study are administered and are supplied a liquid diet one day before surgery without bowel preparation.
- After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
Detailed description
Enrollment of patients
- Before the patients are enrolled in this study, they give us informed consents.
- A liquid diet is supplied beginning from the morning of the day prior to operation to the midnight.
Operation and postoperative management
- All procedures are approached by laparoscopic surgery, and partial gastrectomy with lymph node dissection are performed.
- The patients who are considered to be difficult to progress early oral feeding in surgical field are excluded from the study.
- Nasogastric tube is not applied to patients.
- Postoperative pain is managed by non-opioid pain killer.
- The patients are started on sips of water on the first postoperative day.
- If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them.
- We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
Evaluation of patients
- The patients are followed up to 30 days after discharge from hospital, and we check whether they are tolerable without any compliant and are readmitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early recovery | Experimental | Dietary Supplement: Early recoveryPatients who enroll in this arm are supplied a liquid diet one day before surgery without bowel preparation. After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are diagnosed with gastric adenocarcinoma
- 65 years old and blew
- Patients are expected to be undergone distal subtotal gastrectomy
- No complication by gastric cancer
- No synchronous metastatic lesions
Key exclusion criteria (3 listed)
- Previous gastrectomy history
- Combined surgery due to synchronous malignancy
- Patients with major organ dysfunction
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 recoveryThe patients are started on sips of water on the first postoperative day. If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them. We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination. | Dietary supplement | Early recovery |
Primary outcome
Drop rate from critical pathway
Time frame: 4 days
It is defined as the proportion of dropped patients from 4 days critical pathway
4 secondary outcomes
Postoperative pain
Time frame: 7 days
Postoperative complication
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
Recovery after surgery
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Derived from this study: PubMed 31930513Roh CK, Son SY, Lee SY, Hur H, Han SU. Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single-center phase II clinical trial for safety and efficacy. J Surg Oncol. 2020 Mar;121(4):662-669. doi: 10.1002/jso.25837. Epub 2020 Jan 12.
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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.
Hoon Hur, Prof. principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early recovery in people with Fasting and Malignant Neoplasm of Stomach, run by Ajou University School of Medicine at 1 site in South Korea.
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 7 inclusion and 3 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 20 Jul 2012. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hoon Hur, Prof. (+82-31-219-5200, hhcmc75@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop rate from critical pathway (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642953, which also lists 1 linked publication.
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 20 Jul 2012.