NCT04748081

Brief Summary

This study examined long-term incidence rates of major bleeding associated with hepatectomy. The investigators used data from Taiwan's National Health Insurance Research Database. Patients who underwent hepatectomy between 2000 and 2012 were identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes. Variables including gender, age, comorbidities, and prescribed medications were matched between cases and controls. A total of 1,053 patients with hepatectomy and 4,212 matched non-hepatectomy subjects were included in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2000

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

13 years

First QC Date

February 3, 2021

Last Update Submit

February 8, 2021

Conditions

Gastrointestinal HemorrhagePostoperative HemorrhageSurgery--Complications

Keywords

Gastrointestinal hemorrhageHepatectomyPostoperative hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Incident diagnosis of major bleeding

    Major bleeding consists of 3 categories: intracranial bleeding (ICD-9-CM; 430, 431, 432.0, 432.1, 432.9, 852.0, 852.2, 852.4, 853.0), gastrointestinal (GI) bleeding (ICD-9-CM; 456.0, 456.20, 530.7, 531, 531.2, 531.4, 531.6, 532, 532.2, 532.4, 532.6, 533, 533.2, 533.4, 533.6, 534, 534.2, 534.4, 534.6, 535.01, 535.11, 535.21, 535.31, 535.41, 535.51, 535.61, 535.71, 537.83, 537.84, 562.02, 562.03, 562.12, 562.13, 569.3, 569.85, 578) and other sites bleeding \[ICD-9-CM; 336.1, 363.6, 372.72, 376.32, 377.42, 379.23 (eye); 593.81, 866.01, 866.02, 866.11, 866.12 (kidney); 719.1 (joint); 729.92 (soft tissue); 423.0 (heart); 772.5 (adrenal gland), 626.8, 626.9 (uterine)\].

    From the the earliest date that patients underwent hepatectomy to the date of an incident diagnosis of major bleeding, December 31, 2015 or withdraw from National Health Insurance Research Database (NHIRD).

Study Arms (2)

Surgery cohort

Patients who underwent hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4) between 2000 and 2012 were identified as the surgery cohort.

Procedure: hepatectomy

Control cohort

Patients without any record of hepatectomy between 2000 and 2012 were defined as the control cohort.

Interventions

hepatectomyPROCEDURE

hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4)

Surgery cohort

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4) between 2000 and 2012, and without past history of coagulation defects and bleeding episodes.

You may qualify if:

  • Patients who underwent hepatectomy between 2000 and 2012.

You may not qualify if:

  • Patients younger than 20 years of age
  • Patients diagnosed with coagulation defects or had a pre-existing bleeding episode before the earliest date that patients underwent hepatectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhagePostoperative Hemorrhage

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 10, 2021

Study Start

January 1, 2000

Primary Completion

December 31, 2012

Study Completion

December 31, 2018

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)