NCT03131492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

March 24, 2017

Last Update Submit

September 28, 2022

Conditions

Ovarian Neoplasms MalignantAnastomotic Leak

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery.

    Within the first six days after the surgery

Interventions

Blood testDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed of an advenced ovarian cancer who need an intestinal resection during ovarian surgery.

You may qualify if:

  • Ovarian cancer stage III-IV
  • Intestinal resection needed

You may not qualify if:

  • Infection diagnosed at time of surgery.
  • Urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (5)

  • 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.

    PMID: 22968068BACKGROUND

  • 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.

    PMID: 22222182BACKGROUND

  • 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.

    PMID: 26136929BACKGROUND

  • 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.

    PMID: 23478615BACKGROUND

  • 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.

    PMID: 26865894BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • 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

    STUDY DIRECTOR

  • José Luis Sánchez-Iglesias, MD

    Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 27, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)