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

January 22, 2015 updated by: Amalie Bøggild, MD, Hvidovre University Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Rectal cancer
Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days after surgery
30 days after surgery
Peroperative Bleeding
Time Frame: Day 1
Peroperative blood loss measured in mL.
Day 1
Length of Hospital Stay
Time Frame: Time of Discharge (3-80 days after surgery, mean: 11 days)
Days in hospital after surgery.
Time of Discharge (3-80 days after surgery, mean: 11 days)
Short term complications
Time Frame: Time of Discharge (3-80 days after surgery, mean: 11 days)
Complications at the time of discharge classified according to Clavien Dindo, groups 0-5.
Time of Discharge (3-80 days after surgery, mean: 11 days)
Readmission within 30 days after surgery
Time Frame: 30 days after discharge
+/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge.
30 days after discharge
Duration of surgery
Time Frame: Day 1
Duration of surgery measured in minutes.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 31, 2014

First Posted (ESTIMATE)

June 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMIandRectalCancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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