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ObesityNCT01737515

Investigation of Waist Circumference and Waist/Hip Ratio as a Predictive Risk Factor for Morbidity and Mortality After Colorectal Surgery

An observational study of Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite advances in surgical technique, preoperative patient evaluation and post-operative care, elective colorectal surgery carries a risk of mortality of approximately 2% and a morbidity rate ranging from 20-40%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Abdominal waist and hip circumference
How many people
1,415 participants
Where
No sites listed yet
Study dates
Nov 2008to Jun 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients for whom elective colorectal resectional surgery (open and laparoscopic) is indicated.

Who may be able to join

  • colorectal cancer
  • diverticulitis
  • colonic volvulus
  • colorectal polyp

Who cannot join

  • Age < 18 years
  • Inability to give informed consent
  • Emergency surgery
  • Pregnancy
  • Comorbidity resulting in altered abdominal circumference measurement:
  • ascites secondary to chronic liver disease peritoneal carcinomatosis intestinal obstruction abdominal mass lesions >20cm diameter on CT scan. pre-existing abdominal stoma incisional hernia
  • Inflammatory bowel disease: it is recognised that this group of patients carries a well-recognised increased risk of a number of adverse outcomes (e.g. venous thrombo-embolism) and elevated inflammatory parameters therefore it is proposed to exclude this group from the study.

About this study

Despite advances in surgical technique, preoperative patient evaluation and post-operative care, elective colorectal surgery carries a risk of mortality of approximately 2% and a morbidity rate ranging from 20-40%. Risk prediction is important for two reasons: it informs decision-making in individual cases before surgery (part of informed consent) and allows the comparison of actual outcome with predicted outcome. A number of scoring systems for assessing risk of death after surgery have been developed. They vary from simple scores based on a few variables to highly complex mathematical models requiring detailed data input. Recently, the Association Française de Chirurgie conducted a multicentre study to develop and validate a 4-item predictive score of mortality after colorectal resection which has good predictive value and is simple to use.

Although many surgeons associate obesity with adverse outcomes, recent large, well-designed studies have been unable to show that obesity (defined as Body Mass Index (BMI) >30) is an independent risk factor for major morbidity or mortality after general abdominal surgery. Recently abdominal obesity (waist measurement >102cm in men and >88cm in women) has been shown to have better correlation with cardiovascular disease than BMI and is strongly associated with a clustering of risk factors for cardiovascular disease and diabetes (insulin resistance, hyperglycaemia, hypertension, dyslipidaemia and abdominal obesity) known as the metabolic syndrome. Waist circumference and waist/hip ratio are measures of abdominal obesity that correlate with the amount of intra-abdominal rather than subcutaneous or general body fat and may be a better measure of the risk of intra-operative complications and post-operative morbidity following abdominal surgery than BMI.

Read more

The study will be prospective and multicentred, with 28 participating units in Belgium, France, Switzerland and Sweden. The coordinating centre will be UCL St Luc. The study will start on 1st September 2008 and will aim to include a minimum of 1000 patients. Consecutive patients undergoing elective colorectal resectional surgery for cancer or diverticulitis will be included. In addition to normal preoperative assessment, waist and hip circumference will be measured before surgery and specific data will be collected on intra and post-operative complications and mortality. Data will be recorded using an encrypted, anonymous database using variables carefully selected to assess short and long term outcomes. The study will be the first of its kind to investigate abdominal obesity as a predictive risk factor for colorectal surgery and will also be one of the biggest prospective studies of morbidity after colorectal surgery.

The aims of the study are a) to assess if waist measurement or waist/hip ratio is a better predictive risk factor for complications or mortality after colorectal surgery than BMI, and b) if this measurement adds accuracy to the AFC score in risk prediction.

Conditions
Obesity
Being tested
Abdominal waist and hip circumference
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal waist and hip circumferenceOther

    Abdominal waist and hip circumferences are measured clinically with a ruler as part of the standard pre-operative physical examination

Study groups in NCT01737515
Study groupRoleWhat they receive
Main groupConsecutive patients undergoing colorectal surgery for benign or malignant colorectal disease without any diversion from the standard of care
Receives: Other: Abdominal waist and hip circumference

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity after colorectal surgery

    Measured: 30 days postoperatively

  2. Mortality after colorectal surgery

    Measured: 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737515
Sponsor's protocol ID
AbdoWaistHip
Status last verified
Nov 2012
First submitted
27 Nov 2012
Last updated
29 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity after colorectal surgery (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.

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