CancerNCT01062334
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer
A study testing Peritoneal Microdialysis, CT-scan, leakage scoring in people with Cancer, run by Odense University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Peritoneal Microdialysis, CT-scan, leakage scoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological verified cancer
- The cancer must be located in rectum maximum of 15 cm.
- Diverting stoma is allowed
- Perioperative radio-chemotherapy is allowed
Who cannot join
- Disseminated cancer
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Odense University hospital
Odense C, Fyn, 5000
Mark Ellebæk Pedersen, MD, 40880511, markep01@gmail.com
- Recruiting
Vejle hospital
Vejle, 7100
Mark Ellebæk Pedersen, MD, 40880511, markep01@gmail.com
About this study
Official title: Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications
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.
Read the detailed description
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. ------
- Conditions
- Cancer
- Being tested
- Peritoneal Microdialysis, CT-scan, leakage scoring
- Keywords
- Anastomotic leakage after LAR
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Microdialysis, CT-scan, leakage scoringProcedure or surgery
Peritoneal microdialysis CT-scan before discharge Leakage scoring daily
| Study group | Role | What they receive |
|---|---|---|
| Microdialysis | Experimental | Not described Receives: Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
Measured: Clinically complications with in 30th days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital
- Responsible party
- Principal investigator, Mark Ellebaek Pedersen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062334
- Sponsor's protocol ID
- S-20090147
- Status last verified
- Feb 2014
- First submitted
- 28 Jan 2010
- Last updated
- 5 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications
- ClinicalTrials.gov ID
- NCT01062334
- Acronym / sponsor ID
- S-20090147
- Conditions
- Cancer
- Keywords
- Anastomotic leakage after LAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Vejle Hospital
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (estimated)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. ------
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microdialysis | Experimental | Procedure: Peritoneal Microdialysis, CT-scan, leakage scoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological verified cancer
- The cancer must be located in rectum maximum of 15 cm.
- Diverting stoma is allowed
- Perioperative radio-chemotherapy is allowed
Key exclusion criteria (1 listed)
- Disseminated cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal Microdialysis, CT-scan, leakage scoringPeritoneal microdialysis CT-scan before discharge Leakage scoring daily | Procedure or surgery | Microdialysis |
Primary outcome
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
Time frame: Clinically complications with in 30th days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal Microdialysis, CT-scan, leakage scoring in people with Cancer, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Ellebæk Pedersen, MD (40880511, markep01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio (time frame: Clinically complications with in 30th days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.