NCT01620697

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

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, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

3.4 years

First QC Date

June 13, 2012

Last Update Submit

June 15, 2012

Conditions

Visceral ObesityColorectal SurgeryRisk Factor

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications (Clavien-Dindo classification)

    30 days

Secondary Outcomes (2)

  • Duration of the operation

    From incision to dressing of the wound

  • Rate of conversion

    From incision to dressing of the wound

Study Arms (1)

Perirenal fat

Procedure: Colorectal surgery

Interventions

Colorectal surgeryPROCEDURE

Colorectal surgery

Perirenal fat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We included all elective colorectal resections for benign, malignant and inflammatory diseases, admitted to the Geneva university hospital, Geneva, Switzerland

You may qualify if:

  • elective colorectal resection

You may not qualify if:

  • age under 18
  • emergency condition
  • immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Minoa Jung, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Francesco Volonte, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Philippe Morel, MD

    University Hospital, Geneva

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations

CH(1)