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


N/A
N/A
N/A
Not Enrolling
Both
Cancer of Rectum

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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


Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses
during the postoperative period until discharge. Subcutaneous microdialysis serve as
control. 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.

Patients undergoing abdomino-perineal rectal resection will serve as a control group.

A total of 50 patients will be included in this pilot study. The results of the peritoneal
microdialyses will be compared with the clinical course 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 or the sigmoid colon

- Diverting stoma is allowed

- Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

- Disseminated cancer

- ASA-group 4 ore higher

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

anastomotic leakage

Outcome Time Frame:

within 30 days

Safety Issue:

No

Principal Investigator

Niels Qvist, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Ethics Committee

Study ID:

VF20050008

NCT ID:

NCT00271986

Start Date:

January 2006

Completion Date:

January 2008

Related Keywords:

  • Cancer of Rectum
  • Peritoneal microdialysis
  • Low anterior resection
  • Recto-sigmoid cancer
  • Anastomotic leakage
  • Rectal Neoplasms
  • Sigmoid Neoplasms
  • Anastomotic Leak

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