Early Recovery After Gastric Cancer Surgery
Primary Purpose
Fasting, Malignant Neoplasm of Stomach
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early recovery
Sponsored by
About this trial
This is an interventional treatment trial for Fasting focused on measuring Gastric cancer surgery, Early oral feeding, Fast track surgery
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
Sites / Locations
- Ajou University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early recovery
Arm Description
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.
Outcomes
Primary Outcome Measures
Drop rate from critical pathway
It is defined as the proportion of dropped patients from 4 days critical pathway
Secondary Outcome Measures
Postoperative pain
It is defined as the change of pain scale after surgery
Postoperative complication
It is defined the complications after surgery
Postoperative mortality
It will defined as the death case during 30 days after surgery
Recovery after surgery
It is defined as the time to first flatus and recovery of bowel activity after surgery
Full Information
NCT ID
NCT01642953
First Posted
July 14, 2012
Last Updated
July 18, 2012
Sponsor
Ajou University School of Medicine
Collaborators
JW Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01642953
Brief Title
Early Recovery After Gastric Cancer Surgery
Official Title
Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting, Malignant Neoplasm of Stomach
Keywords
Gastric cancer surgery, Early oral feeding, Fast track surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early recovery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Early recovery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drop rate from critical pathway
Description
It is defined as the proportion of dropped patients from 4 days critical pathway
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
It is defined as the change of pain scale after surgery
Time Frame
7 days
Title
Postoperative complication
Description
It is defined the complications after surgery
Time Frame
30 days
Title
Postoperative mortality
Description
It will defined as the death case during 30 days after surgery
Time Frame
30 days
Title
Recovery after surgery
Description
It is defined as the time to first flatus and recovery of bowel activity after surgery
Time Frame
7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoon Hur, Prof.
Phone
+82-31-219-5200
Email
hhcmc75@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoon Hur, Prof.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoon Hur, prof.
Phone
+82-31-219-5200
Email
hhcmc75@naver.com
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, prof.
Phone
+82-31-219-5200
Email
hansu@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, Professor
First Name & Middle Initial & Last Name & Degree
Cheul Soo Byun, Instructor
12. IPD Sharing Statement
Citations:
PubMed Identifier
31930513
Citation
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.
Results Reference
derived
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Early Recovery After Gastric Cancer Surgery
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