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

Conditions
Obesity
Rectal Cancer
Registration Number
NCT02153853
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
335
Inclusion Criteria
  • Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark.
Exclusion Criteria
  • No exclusion criteria

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Conversion rateDay 1

Amount of patients undergoing conversion from laparoscopic to open surgery.

Secondary Outcome Measures
NameTimeMethod
30-day mortality30 days after surgery
Peroperative BleedingDay 1

Peroperative blood loss measured in mL.

Length of Hospital StayTime of Discharge (3-80 days after surgery, mean: 11 days)

Days in hospital after surgery.

Short term complicationsTime of Discharge (3-80 days after surgery, mean: 11 days)

Complications at the time of discharge classified according to Clavien Dindo, groups 0-5.

Readmission within 30 days after surgery30 days after discharge

+/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge.

Duration of surgeryDay 1

Duration of surgery measured in minutes.

Trial Locations

Locations (1)

Hvidovre Hospital

🇩🇰

Copenhagen, Denmark

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