Visceral Obesity and Colorectal Surgery | NCT01620697

Studies
Visceral Obesity and Colorectal Surgery

NCT01620697

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Jun 18, 2012Estimated

Enrollment

224Actual

Phase

Not provided

Conditions

Visceral Obesity
Colorectal Surgery
Risk Factor

Interventions

Colorectal surgery

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2012

Last Update Posted Date

Jun 18, 2012Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perirenal fat			Procedure: Colorectal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colorectal surgery	Procedure	Colorectal surgery	Perirenal fat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	Postoperative complications (Clavien-Dindo classification)	30 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of the operation		From incision to dressing of the wound
Rate of conversion		From incision to dressing of the wound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective colorectal resection

Exclusion Criteria:

age under 18
emergency condition
immunosuppression

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minoa Jung, MD	University Hospital, Geneva	Principal Investigator
Francesco Volonte, MD	University Hospital, Geneva	Principal Investigator
Philippe Morel, MD	University Hospital, Geneva	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Geneva		Geneva	Canton of Geneva	1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D056128	Obesity, Abdominal

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided