Early Dehiscence Markers in Ovarian Cancer Surgery (EDMOCS)

September 28, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery

EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer surgery requiring intestinal resection. These markers have already been positively tested in colorectal cancer surgery, but not yet in ovarian surgery.

Patients undergoing intestinal resection in ovarian cancer surgery will be included. C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari de la Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed of an advenced ovarian cancer who need an intestinal resection during ovarian surgery.

Description

Inclusion Criteria:

  • Ovarian cancer stage III-IV
  • Intestinal resection needed

Exclusion Criteria:

  • Infection diagnosed at time of surgery.
  • Urgent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels
Time Frame: Within the first 30 days after the surgery
To evaluate whether C-reactive protein (CRP) and procalcitonin (PCT) can predict anastomotic leak before early discharge.
Within the first 30 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery.
Time Frame: Within the first six days after the surgery
Defining normal range values of C-Reactive Protein and Procalcitonin during postoperative ovarian cancer surgery.
Within the first six days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Study Director: Antonio Gil-Moreno, MD, Head of Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital
  • Study Director: Asunción Pérez-Benavente, MD, Head of Unit of Gynecology Oncology Department of Obstetrics and Gynecology
  • Principal Investigator: José Luis Sánchez-Iglesias, MD, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AMI)68/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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