Clinical trial NCT03131492: Early Dehiscence Markers in Ovarian Cancer Surgery
Official title: Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms Malignant
Anastomotic Leak
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed of an advenced ovarian cancer who need an intestinal resection during ovarian surgery.

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.


Eligibility criteria: Inclusion Criteria:

* Ovarian cancer stage III-IV
* Intestinal resection needed

Exclusion Criteria:

* Infection diagnosed at time of surgery.
* Urgent surgery

Primary outcomes:
measure: Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels
timeFrame: Within the first 30 days after the surgery
Secondary outcomes:
measure: C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery.
timeFrame: Within the first six days after the surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d'Hebron
Study officials:
affiliation: Head of Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital
name: Antonio Gil-Moreno, MD
role: STUDY_DIRECTOR
affiliation: Head of Unit of Gynecology Oncology Department of Obstetrics and Gynecology
name: Asunción Pérez-Benavente, MD
role: STUDY_DIRECTOR
affiliation: Department of Obstetrics and Gynecology
name: José Luis Sánchez-Iglesias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.