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Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications


Patients undergoing LAR for rectum cancer is subjected to peritoneal microdialyses during
the postoperative period until the 7. postoperative day. Samples are collected every 4-hour.
Samples will be analyzed continuously but the results will not be included in the clinical
evaluation of the patient. Before removing the microdialysis catheter a CT whit rectal enema
is preformed. Every day the patient will be evaluated whit a standardised clinical scoring
system with attention at anastomotic leakage.

A total of 150 patients will be included in this study. The results of the peritoneal
microdialyses will be compared with the clinical scorings system in each patient. The
results form the uncomplicated courses will be used to define the normal variations in
peritoneal microdialysis. This will be compared to results from patients with various
complications.

The study is approved by the local scientific ethical committee No. ------


Inclusion Criteria:



- Histological verified cancer

- The cancer must be located in rectum maximum of 15 cm.

- Diverting stoma is allowed

- Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

- Disseminated cancer

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

Clinically complications with in 30th days after surgery

Safety Issue:

No

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

S-20090147

NCT ID:

NCT01062334

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Cancer
  • Anastomotic leakage after LAR
  • Anastomotic Leak

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