Does Obesity Increase the Risk of Conversion and Short Te... | NCT02153853

Studies
Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?

NCT02153853

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2015Estimated

Enrollment

335Actual

Phase

Not provided

Conditions

Rectal Cancer
Obesity

Interventions

Not provided

Countries

Denmark

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

May 29, 2014

First Submission Date that Met QC Criteria

May 31, 2014

First Posted Date

Jun 3, 2014Estimated

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

Jan 22, 2015

Last Update Posted Date

Jan 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications.

The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer.

The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality.

The investigators hypothesise that increased BMI does not increase the risk of conversion.

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

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

335Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rectal cancer		Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion rate	Amount of patients undergoing conversion from laparoscopic to open surgery.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Peroperative Bleeding	Peroperative blood loss measured in mL.	Day 1
Length of Hospital Stay	Days in hospital after surgery.	Time of Discharge (3-80 days after surgery, mean: 11 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark.

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rectal cancer treated with laparoscopic surgery at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Denmark.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital		Copenhagen			Denmark

Label	URL
Hvidovre Hospital	View source

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D009765	Obesity

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided