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
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|
|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|
Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark.
- Conversion rate [ Time Frame: Day 1 ]Amount of patients undergoing conversion from laparoscopic to open surgery.
- Peroperative Bleeding [ Time Frame: Day 1 ]Peroperative blood loss measured in mL.
- Length of Hospital Stay [ Time Frame: Time of Discharge (3-80 days after surgery, mean: 11 days) ]Days in hospital after surgery.
- 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.
- 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-day mortality [ Time Frame: 30 days after surgery ]
- Duration of surgery [ Time Frame: Day 1 ]Duration of surgery measured in minutes.
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