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Clinical Trials/NCT01642953
NCT01642953
Unknown
Phase 2

Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery

Ajou University School of Medicine1 site in 1 country109 target enrollmentJuly 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Fasting
Sponsor
Ajou University School of Medicine
Enrollment
109
Locations
1
Primary Endpoint
Drop rate from critical pathway
Last Updated
13 years ago

Overview

Brief 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.
  • 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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
August 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Hoon Hur

Assistant Professor

Ajou University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Previous gastrectomy history
  • Combined surgery due to synchronous malignancy
  • Patients with major organ dysfunction

Outcomes

Primary Outcomes

Drop rate from critical pathway

Time Frame: 4 days

It is defined as the proportion of dropped patients from 4 days critical pathway

Secondary Outcomes

  • Postoperative pain(7 days)
  • Postoperative complication(30 days)
  • Postoperative mortality(30 days)
  • Recovery after surgery(7 days)

Study Sites (1)

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