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Early Recovery After Gastric Cancer Surgery

Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01642953
Enrollment
109
Registered
2012-07-17
Start date
2012-07-31
Completion date
2014-08-31
Last updated
2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Malignant Neoplasm of Stomach

Keywords

Gastric cancer surgery, Early oral feeding, Fast track surgery

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.

Interventions

DIETARY_SUPPLEMENTEarly recovery

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.

Sponsors

JW Pharmaceutical
CollaboratorINDUSTRY
Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Drop rate from critical pathway4 daysIt is defined as the proportion of dropped patients from 4 days critical pathway

Secondary

MeasureTime frameDescription
Postoperative pain7 daysIt is defined as the change of pain scale after surgery
Postoperative complication30 daysIt is defined the complications after surgery
Postoperative mortality30 daysIt will defined as the death case during 30 days after surgery
Recovery after surgery7 daysIt is defined as the time to first flatus and recovery of bowel activity after surgery

Countries

South Korea

Contacts

Primary ContactHoon Hur, Prof.
hhcmc75@naver.com+82-31-219-5200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026