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

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ClinicalTrials.gov Identifier: NCT02153853
Recruitment Status : Unknown
Verified January 2015 by Amalie Bøggild, MD, Hvidovre University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 3, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Amalie Bøggild, MD, Hvidovre University Hospital

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.


Condition or disease
Rectal Cancer Obesity

Study Type : Observational
Actual Enrollment : 335 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?
Study Start Date : June 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

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



Primary Outcome Measures :
  1. Conversion rate [ Time Frame: Day 1 ]
    Amount of patients undergoing conversion from laparoscopic to open surgery.


Secondary Outcome Measures :
  1. Peroperative Bleeding [ Time Frame: Day 1 ]
    Peroperative blood loss measured in mL.

  2. Length of Hospital Stay [ Time Frame: Time of Discharge (3-80 days after surgery, mean: 11 days) ]
    Days in hospital after surgery.

  3. 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.

  4. Readmission within 30 days after surgery [ Time Frame: 30 days after discharge ]
    +/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge.

  5. 30-day mortality [ Time Frame: 30 days after surgery ]
  6. Duration of surgery [ Time Frame: Day 1 ]
    Duration of surgery measured in minutes.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rectal cancer treated with laparoscopic surgery at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Denmark.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153853


Locations
Denmark
Hvidovre Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Hvidovre University Hospital

Responsible Party: Amalie Bøggild, MD, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02153853     History of Changes
Other Study ID Numbers: BMIandRectalCancer
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms