Early Dehiscence Markers in Ovarian Cancer Surgery

Anastomotic Leak Clinical Trial

— EDMOCS  

Official title:

Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131492
• Other study ID #: PR(AMI)68/2017
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ovarian cancer stage III-IV

• Intestinal resection needed

Exclusion Criteria:

• Infection diagnosed at time of surgery.

• Urgent surgery

Related Conditions & MeSH terms

• Anastomotic Leak
• Neoplasms
• Ovarian Neoplasms
• Ovarian Neoplasms Malignant

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari de la Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View 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. Epub 2015 Mar 12. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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