Early Recovery After Gastric Cancer Surgery

Fasting Clinical Trial

Official title:

Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01642953
• Other study ID #: AJIRB-MED-MDB-12-002
• Status: Recruiting
• Phase: Phase 2
• First received: July 14, 2012
• Last updated: July 18, 2012
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: July 2012
• Source: Ajou University School of Medicine
• Contact: Hoon Hur, Prof.
• Phone: +82-31-219-5200
• Email: hhcmc75[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fasting
• Malignant Neoplasm of Stomach
• Neoplasms
• Stomach Neoplasms

Intervention

Dietary Supplement:
• Early 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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop rate from critical pathway	It is defined as the proportion of dropped patients from 4 days critical pathway	4 days	No
Secondary	Postoperative pain	It is defined as the change of pain scale after surgery	7 days	No
Secondary	Postoperative complication	It is defined the complications after surgery	30 days	Yes
Secondary	Postoperative mortality	It will defined as the death case during 30 days after surgery	30 days	Yes
Secondary	Recovery after surgery	It is defined as the time to first flatus and recovery of bowel activity after surgery	7 days	No

External Links

•   Ajou University Hospital
•   Ajou University Hospital IRB