Visceral ObesityNCT01620697
Visceral Obesity and Colorectal Surgery
An observational study of Visceral Obesity and Colorectal Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral Obesity, Colorectal Surgery, Risk Factor
- What is being tested?
- Colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Jun 2012
- Phase
- Observational
- 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
Study population: We included all elective colorectal resections for benign, malignant and inflammatory diseases, admitted to the Geneva university hospital, Geneva, Switzerland
Who may be able to join
- elective colorectal resection
Who cannot join
- age under 18
- emergency condition
- immunosuppression
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Value of Perirenal Fat Surface as a Risk Factor for Morbidity After Elective Colorectal Surgery
While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated.
The investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass index (BMI) and Waist- Hip ratio (WHR).
- Conditions
- Visceral Obesity, Colorectal Surgery, Risk Factor
- Being tested
- Colorectal surgery
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal surgeryProcedure or surgery
Colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| Perirenal fat | Not described Receives: Procedure: Colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications (Clavien-Dindo classification)
Measured: 30 days
Secondary outcomes (2)
Duration of the operation
Measured: From incision to dressing of the wound
Rate of conversion
Measured: From incision to dressing of the wound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Volonté, MD, University Hospital, Geneva
- Investigators
- Minoa Jung, MD, Principal investigator, University Hospital, GenevaFrancesco Volonte, MD, Principal investigator, University Hospital, GenevaPhilippe Morel, MD, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620697
- Sponsor's protocol ID
- FAT-40-GVA
- Status last verified
- Jun 2012
- First submitted
- 13 Jun 2012
- Last updated
- 18 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Perirenal Fat Surface as a Risk Factor for Morbidity After Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01620697
- Acronym / sponsor ID
- FAT-40-GVA
- Conditions
- Visceral Obesity, Colorectal Surgery, Risk Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jun 2012 (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.
While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated.
The investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass index (BMI) and Waist- Hip ratio (WHR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perirenal fat | – | Procedure: Colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included all elective colorectal resections for benign, malignant and inflammatory diseases, admitted to the Geneva university hospital, Geneva, Switzerland
Key inclusion criteria (1 listed)
- elective colorectal resection
Key exclusion criteria (3 listed)
- age under 18
- emergency condition
- immunosuppression
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 |
|---|---|---|
| Colorectal surgeryColorectal surgery | Procedure or surgery | Perirenal fat |
Primary outcome
Postoperative complications
Time frame: 30 days
Postoperative complications (Clavien-Dindo classification)
2 secondary outcomes
Duration of the operation
Time frame: From incision to dressing of the wound
Rate of conversion
Time frame: From incision to dressing of the wound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
Minoa Jung, MD principal investigator
University Hospital, Geneva
Francesco Volonte, MD principal investigator
University Hospital, Geneva
Philippe Morel, MD study chair
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Obesity and Colorectal Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days). 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 18 Jun 2012.