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Early Dehiscence Markers in Ovarian Cancer Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03131492
Acronym
EDMOCS
Enrollment
92
Registered
2017-04-27
Start date
2017-03-01
Completion date
2021-07-31
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Ovarian Neoplasms Malignant

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBlood test

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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ovarian cancer stage III-IV * Intestinal resection needed

Exclusion criteria

* Infection diagnosed at time of surgery. * Urgent surgery

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levelsWithin the first 30 days after the surgeryTo evaluate whether C-reactive protein (CRP) and procalcitonin (PCT) can predict anastomotic leak before early discharge.

Secondary

MeasureTime frameDescription
C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery.Within the first six days after the surgeryDefining normal range values of C-Reactive Protein and Procalcitonin during postoperative ovarian cancer surgery.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026