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Early Recovery After Gastric Cancer Surgery

This study is currently recruiting participants.
Verified July 2012 by Ajou University School of Medicine
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Hoon Hur, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01642953
First received: July 14, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Fasting
Malignant Neoplasm of Stomach
 Dietary Supplement: Early recovery
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • Drop rate from critical pathway [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    It is defined as the proportion of dropped patients from 4 days critical pathway


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    It is defined as the change of pain scale after surgery

  • Postoperative complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    It is defined the complications after surgery

  • Postoperative mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    It will defined as the death case during 30 days after surgery

  • Recovery after surgery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    It is defined as the time to first flatus and recovery of bowel activity after surgery


Estimated Enrollment: 109
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

 Dietary Supplement: 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.

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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642953

Contacts
Contact: Hoon Hur, Prof. +82-31-219-5200 hhcmc75@naver.com

Locations
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Hoon Hur, prof.     +82-31-219-5200     hhcmc75@naver.com    
Contact: Sang-Uk Han, prof.     +82-31-219-5200     hansu@ajou.ac.kr    
Sub-Investigator: Sang-Uk Han, Professor            
Sub-Investigator: Cheul Soo Byun, Instructor            
Sponsors and Collaborators
Ajou University School of Medicine
JW Pharmaceutical
Investigators
Principal Investigator: Hoon Hur, Prof. Ajou University School of Medicine
  More Information

Additional Information:
Ajou University Hospital IRB  This link exits the ClinicalTrials.gov site
Ajou University Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hoon Hur, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01642953     History of Changes
Other Study ID Numbers: AJIRB-MED-MDB-12-002
Study First Received: July 14, 2012
Last Updated: July 18, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
Gastric cancer surgery
Early oral feeding
Fast track surgery

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013