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.
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 group | Role | What they receive |
|---|---|---|
| Main group | Consecutive 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.
Morbidity after colorectal surgery
Measured: 30 days postoperatively
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.
- First posted29 Nov 2012 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex H Kartheuser, MD, PhD, MSc, Study chair, Colorectal Surgery Unit, Cliniques universitaires Saint-Luc
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Waist Circumference and Waist/Hip Ratio as a Predictive Risk Factor for Morbidity and Mortality After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01737515
- Acronym / sponsor ID
- AbdoWaistHip
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,415 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Other: Abdominal waist and hip circumferenceConsecutive patients undergoing colorectal surgery for benign or malignant colorectal disease without any diversion from the standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom elective colorectal resectional surgery (open and laparoscopic) is indicated.
Key inclusion criteria (4 listed)
- colorectal cancer
- diverticulitis
- colonic volvulus
- colorectal polyp
Key exclusion criteria (7 listed)
- Age < 18 years
- Inability to give informed consent
- Emergency surgery
- Pregnancy
- Comorbidity resulting in altered abdominal circumference measurement:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal waist and hip circumferenceAbdominal waist and hip circumferences are measured clinically with a ruler as part of the standard pre-operative physical examination | Other | Main group |
Primary outcome
Morbidity after colorectal surgery
Time frame: 30 days postoperatively
Mortality after colorectal surgery
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex H Kartheuser, MD, PhD, MSc study chair
Colorectal Surgery Unit, Cliniques universitaires Saint-Luc
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.