Clinical trial NCT01642953: Early Recovery After Gastric Cancer Surgery
Official title: Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fasting
Malignant Neoplasm of Stomach
Keywords: Gastric cancer surgery
Early oral feeding
Fast track surgery
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2012-07-17
Enrollment: 109
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drop rate from critical pathway
timeFrame: 4 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: 7 days
measure: Postoperative complication
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 30 days
measure: Recovery after surgery
timeFrame: 7 days
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Hoon Hur, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roh CK, Son SY, Lee SY, Hur H, Han SU. Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single-center phase II clinical trial for safety and efficacy. J Surg Oncol. 2020 Mar;121(4):662-669. doi: 10.1002/jso.25837. Epub 2020 Jan 12.