Early Recovery After Gastric Cancer Surgery

Trial Title: Early Recovery After Gastric Cancer Surgery

NCT ID: NCT01642953

Condition: Fasting
Malignant Neoplasm of Stomach

Conditions: Official terms:
Stomach Neoplasms
Neoplasms

Conditions: Keywords:
Gastric cancer surgery
Early oral feeding
Fast track surgery

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Early recovery
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.
Arm group label: Early recovery

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.

Criteria for 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

Gender: All

Minimum age: N/A

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ajou University Hospital

Address:
City: Suwon
Zip: 443-721
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Hoon Hur, prof.

Phone: +82-31-219-5200
Email: hhcmc75@naver.com

Contact backup:
Last name: Sang-Uk Han, prof.

Phone: +82-31-219-5200
Email: hansu@ajou.ac.kr

Investigator:
Last name: Sang-Uk Han, Professor
Email: Sub-Investigator

Investigator:
Last name: Cheul Soo Byun, Instructor
Email: Sub-Investigator

Start date: July 2012

Completion date: August 2014

Lead sponsor:
Agency: Ajou University School of Medicine
Agency class: Other

Collaborator:
Agency: JW Pharmaceutical
Agency class: Industry

Source: Ajou University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01642953