EDMOCS: Early Dehiscence Markers in Ovarian Cancer Surgery
Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03131492
Collaborator
(none)
70
1
17
4.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery
Actual Study Start Date
:
Mar 1, 2017
Anticipated Primary Completion Date
:
May 31, 2018
Anticipated Study Completion Date
:
Jul 31, 2018
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Ovarian cancer stage III-IV
-
Intestinal resection needed
Exclusion Criteria:
-
Infection diagnosed at time of surgery.
-
Urgent surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari de la Vall d'Hebron | Barcelona | Spain | 08035 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Garcia-Granero A, Frasson M, Flor-Lorente B, Blanco F, Puga R, Carratalá 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.
- 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. Epub 2015 Mar 12.
- 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.
- 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.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT03131492
Other Study ID Numbers:
- PR(AMI)68/2017
First Posted:
Apr 27, 2017
Last Update Posted:
Apr 27, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: