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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Diagnostic Test | C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery. | Defining normal range values of C-Reactive Protein and Procalcitonin during postoperative ovarian cancer surgery. | Within the first six days after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed of an advenced ovarian cancer who need an intestinal resection during ovarian surgery.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| José Luis Sánchez-Iglesias, MD | Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de la Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968068 | Background | Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd. | |
| 22222182 | Background |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Almeida AB, Faria G, Moreira H, Pinto-de-Sousa J, Correia-da-Silva P, Maia JC. Elevated serum C-reactive protein as a predictive factor for anastomotic leakage in colorectal surgery. Int J Surg. 2012;10(2):87-91. doi: 10.1016/j.ijsu.2011.12.006. Epub 2011 Dec 28. |
| 26136929 | Background | Lu Y, Huang S, Li P, Chen B, Liu W, Chen Z, Yin F. Prognostic evaluation of preoperative serum C-reactive protein concentration in patients with epithelial ovarian cancer. Exp Ther Med. 2015 May;9(5):2003-2007. doi: 10.3892/etm.2015.2350. Epub 2015 Mar 12. |
| 23478615 | Background | Garcia-Granero A, Frasson M, Flor-Lorente B, Blanco F, Puga R, Carratala A, Garcia-Granero E. Procalcitonin and C-reactive protein as early predictors of anastomotic leak in colorectal surgery: a prospective observational study. Dis Colon Rectum. 2013 Apr;56(4):475-83. doi: 10.1097/DCR.0b013e31826ce825. |
| 26865894 | Background | Zawadzki M, Czarnecki R, Rzaca M, Obuszko Z, Velchuru VR, Witkiewicz W. C-reactive protein and procalcitonin predict anastomotic leaks following colorectal cancer resections - a prospective study. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):567-73. doi: 10.5114/wiitm.2015.56999. Epub 2016 Jan 12. |