Study Results
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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UNKNOWN
PHASE2
109 participants
INTERVENTIONAL
2012-07-31
2014-08-31
Brief Summary
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* 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
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* 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Early recovery
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.
Early recovery
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.
Interventions
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Early recovery
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Combined surgery due to synchronous malignancy
* Patients with major organ dysfunction
65 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Ajou University School of Medicine
OTHER
Responsible Party
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Hoon Hur
Assistant Professor
Principal Investigators
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Hoon Hur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Ajou University Hospital
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hoon Hur, prof.
Role: primary
Sang-Uk Han, prof.
Role: backup
References
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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.
Other Identifiers
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AJIRB-MED-MDB-12-002
Identifier Type: -
Identifier Source: org_study_id