UMIN-CTR Clinical Trial

Public title

Comparative evaluation of postoperative mortality prediction models, CORES and NSQIP, in patients with emergency digestive surgery.

Acronym

CORES & NSQIP

Scientific Title

Comparative evaluation of postoperative mortality prediction models, CORES and NSQIP, in patients with emergency digestive surgery.

Scientific Title:Acronym

CORES & NSQIP

Region

Japan

Condition

Digestive surgery diseases requiring emergency operations

Classification by specialty

Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study is undertaken to investigate the efficacy of postoperative mortality prediction models, CORES and NSQIP, in patients who required emergency digestive surgery in a prospective manner. In addition, we will evaluate the possibility of surgical audit between centers using these models.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postoperative 30-day mortality

Key secondary outcomes

In-hospital mortality, postoperative complications, surgical site infections, length of ICU stay

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are included who require emergency operations for disorders of gastrointestinal tract, liver, biliary tract, pancreas, spleen, or peritoneum. Emergency operations are defined as operations in which the surgeons or anesthesiologists judge to start within 24 hours from arrival to improve the prognosis.

Key exclusion criteria

The following patients are excluded;
(1) The patients who receive no treatment via exploratory laparotomy or laparoscopy.
(2) The patients the primary disease of whom are found to be in other fields than digestive disorders during the operations, such as pyometra, bladder necrosis, or rupture of abdominal aortic aneurysm.
(3) The patients who are judged as ASA physical status V; a moribund person who is not expected to survive without the operation.
(4) The patients who already admitted in the hospital and develop the new digestive disorders for emergency operations. For example, the patients had received colectomy and developed abdominal abscess for emergency operation.

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Haga

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Institute for Clinical Research

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto 8600008, Japan

TEL

096-353-6501

Email

yoshio@kumamed.jp

Name of contact person

1st name
Middle name
Last name	Mikiko Kubo

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Center for Clinical Research

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto 8600008, Japan

TEL

096-353-6501

Homepage URL

http://www.nho-kumamoto.jp/medical/clinical-research/cr-observational/cores-nsqip.html

Email

m-kubo@hosp.go.jp

Institute

National Hospital Organization Kumamoto Medical Center

Institute

Department

Personal name

Organization

National Hospital Organization (NHO)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

NHO Sendai Medical Center, NHO Mito Medical Center, NHO Takasaki General Medical Center, NHO Matsumoto Medical Center, NHO Nagoya Medical Center, NHO Kyoto Medical Center, NHO Osaka Medical Center, NHO Osaka Minami Medical Center, NHO Kure Medical Center, NHO Higashihiroshima Medical Center, NHO Kanmon Medical Center, NHO Iwakuni Clinical Center, NHO Kyushu Medical Center, NHO Fukuoka Higashi Medical Center, NHO Ureshino Medical Center, NHO Beppu Medical Center, NHO Miyakonojo Hospital, NHO Kagoshima Medical Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

10

Month

08

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

01

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

2017

Year

03

Month

20

Day

Date trial data considered complete

2017

Year

12

Month

31

Day

Date analysis concluded

2018

Year

03

Month

31

Day

Other related information

1. Study design is a multicenter prospective cohort study.
2. Data to be collected
1) Preoperative data: age, gender, smoking habit, comorbidity (metastatic malignant disease, diabetes mellitus, hypertension, heart failure, sepsis, acute renal failure, use of hemodialysis, use of artificial ventilation, severe COPD, use of steroid), past history of major heart disease or heart surgery, respiratory distress, ADL, height, weight, Japan coma scale, systolic blood pressure, pulse rate, body temperature, respiratory rate, laboratory findings (WBC, immature neutrophils, platelets, BUN, total bilirubin level, creatinine, PaCO2), ascites by image tests, ASA physical status classification
2) Operative findings: wound class, surgical procedures, operation time
3) Data on discharge: principle diagnosis (ICD10)
3. Statistical analyses
1) Evaluation of predictive models
(1) Discrimination power to detect 30-day mortality is determined by area under ROC curve analysis.
(2) Calibration power to detect 30-day mortality is determined by Hosmer-Lemeshow test.
(3) Correlation between the predictive 30-day mortality rates of CORES and NSQIP is evaluated by Spearman's correlation coefficient.
(4) Correlation between severity of postoperative complications and the predictive 30-day mortality rate is evaluated by Spearman's correlation coefficient.
2) Evaluation of surgical quality between centers
(1) Observed-to-estimated mortality ratio (OE ratio) is used to quantitate quality of care between centers.
(2) The correlation between the OE ratios by NSQIP and CORES is determined by Pearson's correlation coefficient.
4. References
1) Miyazaki N, Haga Y, Matsukawa H, et al. The development and validation of the Calculation of post-Operative Risk in Emergency Surgery (CORES) model. Surg Today 2013, published online at http://link.springer.com/article/10.1007%2Fs00595-013-0707-1.

Registered date

2014

Year

11

Month

26

Day

Last modified on

2017

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018329

Single case data URL

Value
https://center6.umin.ac.jp/ice/18329