Fasting Clinical Trial - Early Recovery After Gastric Cancer Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01642953
Study type	Interventional
Source	Ajou University School of Medicine
Contact	Hoon Hur, Prof.
Phone	+82-31-219-5200
Email	hhcmc75@naver.com
Status	Recruiting
Phase	Phase 2
Start date	July 2012
Completion date	August 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.