MedPath

Early Recovery After Gastric Cancer Surgery

Phase 2
Conditions
Fasting
Malignant Neoplasm of Stomach
Interventions
Dietary Supplement: Early recovery
Registration Number
NCT01642953
Lead Sponsor
Ajou University School of Medicine
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
109
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Early recoveryEarly recoveryPatients 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.
Primary Outcome Measures
NameTimeMethod
Drop rate from critical pathway4 days

It is defined as the proportion of dropped patients from 4 days critical pathway

Secondary Outcome Measures
NameTimeMethod
Postoperative pain7 days

It is defined as the change of pain scale after surgery

Postoperative complication30 days

It is defined the complications after surgery

Postoperative mortality30 days

It will defined as the death case during 30 days after surgery

Recovery after surgery7 days

It is defined as the time to first flatus and recovery of bowel activity after surgery

Trial Locations

Locations (1)

Ajou University Hospital

🇰🇷

Suwon, Korea, Republic of

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