Lactate and Complications in Cytoreduction Surgery for Pe... | NCT04307654

Studies
Lactate and Complications in Cytoreduction Surgery for Peritoneal Carcinomatosis

NCT04307654

Sponsor

Hospital General Universitario de Castellón

Status

Completed

Last Update Posted

Mar 13, 2020Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Lactacidemia and Complications

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Jun 2014Actual

Completion Date

Jan 2016Actual

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2020

Last Update Posted Date

Mar 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marta Soriano Hervás, Principal investigator, Hospital General Universitario de CastellónPrincipal Investigator

Lead Sponsor

Hospital General Universitario de CastellónOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis

Detailed Description

Background. Cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. However, this surgery is associated with important complications. The present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit.

Methods. Retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the General University Hospital of Castellón. All patients were admitted to the critical unit immediately after surgery. Lactacidemia levels at the time of admission and discharge from the critical unit were collected. Post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the Clavien-Dindo classification.

Lactacidemia levels were still significantly higher in this group at the time of discharge.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	complications in patients undergoing cytoreduction surgery during the immediate postoperative period in the Intensive Care Unit (ICU) at the General Hospital of Castellón (HGCS) between 2014 and 2016.	2014-2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón.

Exclusion Criteria:

patients without lactic acid levels in the register.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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