Early Dehiscence Markers in Ovarian Cancer Surgery

NCT ID: NCT03131492

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms Malignant Anastomotic Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood test

C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Ovarian cancer stage III-IV
* Intestinal resection needed

Exclusion Criteria

* Infection diagnosed at time of surgery.
* Urgent surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Gil-Moreno, MD

Role: STUDY_DIRECTOR

Head of Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital

Asunción Pérez-Benavente, MD

Role: STUDY_DIRECTOR

Head of Unit of Gynecology Oncology Department of Obstetrics and Gynecology

José Luis Sánchez-Iglesias, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology

Locations

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Hospital Universitari de la Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22968068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22222182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26136929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23478615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26865894 (View on PubMed)

Other Identifiers

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PR(AMI)68/2017

Identifier Type: -

Identifier Source: org_study_id

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