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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02153853
• Other study ID #: BMIandRectalCancer
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 29, 2014
• Last updated: January 22, 2015
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 335
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obesity
• Rectal Cancer

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	Amount of patients undergoing conversion from laparoscopic to open surgery.	Day 1	No
Secondary	Peroperative Bleeding	Peroperative blood loss measured in mL.	Day 1	No
Secondary	Length of Hospital Stay	Days in hospital after surgery.	Time of Discharge (3-80 days after surgery, mean: 11 days)	No
Secondary	Short term complications	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)	No
Secondary	Readmission within 30 days after surgery	+/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge.	30 days after discharge	No
Secondary	30-day mortality		30 days after surgery	No
Secondary	Duration of surgery	Duration of surgery measured in minutes.	Day 1	No