NCT01062334

Brief Summary

Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 28, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

5 years

First QC Date

January 28, 2010

Last Update Submit

February 4, 2014

Conditions

Cancer

Keywords

Anastomotic leakage after LAR

Outcome Measures

Primary Outcomes (1)

  • Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio

    Clinically complications with in 30th days after surgery

Study Arms (1)

Microdialysis

EXPERIMENTAL
Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring

Interventions

Peritoneal Microdialysis, CT-scan, leakage scoringPROCEDURE

Peritoneal microdialysis CT-scan before discharge Leakage scoring daily

Microdialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological verified cancer
  • The cancer must be located in rectum maximum of 15 cm.
  • Diverting stoma is allowed
  • Perioperative radio-chemotherapy is allowed

You may not qualify if:

  • Disseminated cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University hospital

Odense C, Fyn, 5000, Denmark

RECRUITING

Vejle hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mark Ellebæk Pedersen, MD

CONTACT

40880511markep01@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 4, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2015

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

DK(2)