Early Recovery After Gastric Cancer Surgery

Ajou University School of Medicine

Status and phase: Unknown; Phase 2

Conditions: Malignant Neoplasm of Stomach; Fasting

Treatments: Dietary Supplement: Early recovery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01642953

AJIRB-MED-MDB-12-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

Early recovery

Experimental group

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.

Treatment:

Dietary Supplement: Early recovery