NCT01642953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

July 14, 2012

Last Update Submit

July 18, 2012

Conditions

FastingMalignant Neoplasm of Stomach

Keywords

Gastric cancer surgeryEarly oral feedingFast track surgery

Outcome Measures

Primary Outcomes (1)

  • Drop rate from critical pathway

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

    4 days

Secondary Outcomes (4)

  • Postoperative pain

    7 days

  • Postoperative complication

    30 days

  • Postoperative mortality

    30 days

  • Recovery after surgery

    7 days

Study Arms (1)

Early recovery

EXPERIMENTAL

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.

Dietary Supplement: Early recovery

Interventions

Early recoveryDIETARY_SUPPLEMENT

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.

Early recovery

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with gastric adenocarcinoma
  • 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

You may not qualify if:

  • Previous gastrectomy history
  • Combined surgery due to synchronous malignancy
  • Patients with major organ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 443-721, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31930513DERIVED

MeSH Terms

Conditions

FastingStomach Neoplasms

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hoon Hur, Prof.

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoon Hur, Prof.

CONTACT

+82-31-219-5200hhcmc75@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 14, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

KR(1)