Early Dehiscence Markers in Ovarian Cancer Surgery

Completed

• Conditions: Ovarian Neoplasms Malignant; Anastomotic Leak

• Registration Number: NCT03131492
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Ovarian cancer stage III-IV
• Intestinal resection needed

Exclusion Criteria

• Infection diagnosed at time of surgery.
• Urgent surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari de la Vall d'Hebron; 🇪🇸 Barcelona, Spain