Early Dehiscence Markers in Ovarian Cancer Surgery

Overview

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.

Full Title of Study: “Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Diagnostic Test: Blood test
    • C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Ovarian cancer stage III-IV – Intestinal resection needed Exclusion Criteria:

  • Infection diagnosed at time of surgery. – Urgent surgery

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio Gil-Moreno, MD, Study Director, Head of Department of Obstetrics and Gynecology, Vall d’Hebron University Hospital
    • Asunción Pérez-Benavente, MD, Study Director, Head of Unit of Gynecology Oncology Department of Obstetrics and Gynecology
    • José Luis Sánchez-Iglesias, MD, Principal Investigator, Department of Obstetrics and Gynecology

References

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.

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.

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.

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.

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.

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