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Completed

NCT Number: NCT03131492

Early 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.

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Key information

Conditions

Ovarian Neoplasms Malignant Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitari de la Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ovarian cancer stage III-IV
  • Intestinal resection needed

Exclusion criteria

  • Infection diagnosed at time of surgery.
  • Urgent surgery

Treatment and study plan

Blood test

Diagnostic Test

C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: EDMOCS

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 27, 2017
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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