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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001410
Receipt No. R000001713
Scientific Title Establishment of quality of care among hospitals in digestive surgery
Date of disclosure of the study information 2008/10/02
Last modified on 2015/04/06

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Basic information
Public title Establishment of quality of care among hospitals in digestive surgery
Acronym E-PASS study
Scientific Title Establishment of quality of care among hospitals in digestive surgery
Scientific Title:Acronym E-PASS study
Region
Japan

Condition
Condition Patients who underwent elective digestive surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1) To establish a method for quality of care in digestive surgery on short-term outcome using the E-PASS scoring system which we generated;
2) To generate a new scoring system to evaluate a quality of care on long term survival rates following surgery for digestive cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 90-day mortality rate
Key secondary outcomes 2 year and 5 year overall survival rates

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent elective digfestive surgery in operating room.
Key exclusion criteria 1) Patients who refused to join this study
2) Patients who have concomitant malignant tumors of multiple organs
3) Patients who had malignant tumors within past 5 years
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Haga
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Surgery
Zip code
Address 1-5 Ninomaru, chuo-ku, Kumamoto 8600008, Japan
TEL 096-353-6501
Email yoshio@kumamed.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Haga
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of SurgeryDepartment of Surgery
Zip code
Address 1-5 Ninomaru, chuo-ku, Kumamoto 8600008, Japan
TEL 096-353-6501
Homepage URL
Email yoshio@kumamed.jp

Sponsor
Institute National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 10 Month 02 Day

Related information
URL releasing protocol http://www.jcrac.ac/poppy.ac_contents/nho/img/summary/epass_gaiyou.html
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2011&issue=01000&article=00030&type=abstract
Number of participants that the trial has enrolled
Results I. Results for short-term outcomes

In this study, we compared our prediction model E-PASS and its modified form mE-PASS with Western models, American Society of Anesthesiologists (ASA) status-based model and Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in elective gastrointestinal surgery. The area under the receiver operative characteristic curve (AUC, 95% CI) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM and 0.73 (0.63-0.83) for the ASA status-based model. Subsequently, we quantified the ratio of observed- to-estimated in-hospital mortality rates (OE ratio) as a measure of quality. The OE ratios for mE-PASS among large volume hospitals significantly correlated with those for other existing models.

II. Results for long-term outcome gastric cancer resection

We generated a model to predict overall survival (OS) using Cox hazard regression analysis in gastric cancer resection. This model exhibited a better discrimination power (AUC, 95% CI: 0.89, 0.86-0.91) than that for the UICC stage (0.81, 0.77-0.84). Subsequently, we quantified the OE ratio of 5-year OS rates as a measure of quality. The OE ratios among the participating hospitals revealed no significant variation between 0.74 and 1.1.

III. Results for long-term outcome colorectal cancer resection

We generated a model to predict OS using Cox hazard regression analysis in colorectal cancer resection. This model exhibited a better discrimination power (AUC, 95% CI: 0.87, 0.85-0.90) than that for the UICC stage (0.80, 0.76-0.83). Subsequently, we quantified the OE ratio of 5-year OS rates as a measure of quality. The OE ratios among the participating hospitals revealed no significant variation between 0.90 and 1.1.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2012 Year 04 Month 16 Day
Date of closure to data entry
2012 Year 04 Month 16 Day
Date trial data considered complete
2012 Year 04 Month 30 Day
Date analysis concluded

Other
Other related information This study was supported by the grant of National Hospital Organization Multi-Center Clinical Research for Evidence-Based Medicine.

I. The above study results regarding short-term outcome were published in Annals of Surgery.

Haga Y, Ikejiri K, Wada Y, Takahashi T, Ikenaga M, Akiyama N, Koike S, Koseki M, Saitoh T: A multicenter prospective study of surgical audit systems. Ann Surg 2011; 253(1): 194-201.

II. The results for long-term outcome in gastric cancer resection were published in Gastric Cancer.

Haga Y, Wada Y, Takeuchi H, Ikejiri K, Ikenaga M, Kimura O: Evaluation of modified Estimation of Physiologic Ability and Surgical Stress (mE-PASS) in gastric carcinoma surgery. Gastric Cancer. 2012;15(1): 7-14.

III. The results for long-term outcome in colorectal cancer resection were published in World Journal of Surgery.

Haga Y, Ikejiri K, Wada Y, Ikenaga M, Koike S, Nakamura S, Koseki M. The EPOS-CC score: an integration of independent, tumor- and patient-associated risk factors to predict 5-year overall survival following colorectal cancer surgery. Wolrd J Surg, published online at http://link.springer.com/article/10.1007/s00268-015-2962-3.

Management information
Registered date
2008 Year 10 Month 02 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001713

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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