NCT00271986

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 develops.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 22, 2011

Status Verified

May 1, 2008

Enrollment Period

1.8 years

First QC Date

January 3, 2006

Last Update Submit

July 20, 2011

Conditions

Cancer of Rectum

Keywords

Peritoneal microdialysisLow anterior resectionRecto-sigmoid cancerAnastomotic leakage

Outcome Measures

Primary Outcomes (1)

  • anastomotic leakage

    within 30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Loa Anterior Resection (LAR) or rectal cancer

You may qualify if:

  • Histological verified cancer
  • The cancer must be located in rectum or the sigmoid colon
  • Diverting stoma is allowed
  • Perioperative radio-chemotherapy is allowed

You may not qualify if:

  • Disseminated cancer
  • ASA-group 4 ore higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment A

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Niels Qvist, Professor

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

January 1, 2008

Last Updated

July 22, 2011

Record last verified: 2008-05

Locations

DK(1)