Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690179
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-26
Brief Title:
Effects of Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery
Sponsor:
Hospital Universitario Ramon y Cajal
Organization:
Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery Postoperative Complications and Their Impact on Recurrence
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our surgical population and their relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence
This is a retrospective study on a prospective maintains database of complex abdominal wall surgery
We select patients with defects larger than 10 cm from any location W3 of the EHS classification excluding other causes of complex abdominal wall in order to have a more homogeneous sample
Pre-surgical computed tomography CT scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia obesity sarcopenia-obesity or the absence of these normal The CT scans will be reviewed by two trained investigators blinded to postoperative complications and survival In case of disagreement a third investigator will break the tie
The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra L3
The BMI the Visceral Fat Area and the Subcutaneous Fat Area SFA will also be measured With the previous data the VFA SFA ratio will be calculated
The study will be completed with the collection of sociodemographic data comorbidities and presence of risk factors for the development of incisional hernia ASA size and location of the hernia surgical technique postoperative complications according to Clavien-Dindo stay readmission late complications and hernia recurrence Likewise the presence or absence of recurrence will be collected
Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence To evaluate the independent contribution of each variable to the presence of complications a univariate and multivariate logistic regression analysis will be performed
This is a retrospective study on a prospective maintains database of complex abdominal wall surgery
We select patients with defects larger than 10 cm from any location W3 of the EHS classification excluding other causes of complex abdominal wall in order to have a more homogeneous sample
Pre-surgical computed tomography CT scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia obesity sarcopenia-obesity or the absence of these normal The CT scans will be reviewed by two trained investigators blinded to postoperative complications and survival In case of disagreement a third investigator will break the tie
The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra L3
The BMI the Visceral Fat Area and the Subcutaneous Fat Area SFA will also be measured With the previous data the VFA SFA ratio will be calculated
The study will be completed with the collection of sociodemographic data comorbidities and presence of risk factors for the development of incisional hernia ASA size and location of the hernia surgical technique postoperative complications according to Clavien-Dindo stay readmission late complications and hernia recurrence Likewise the presence or absence of recurrence will be collected
Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence To evaluate the independent contribution of each variable to the presence of complications a univariate and multivariate logistic regression analysis will be performed
Detailed Description:
The incidence of incisional hernia after laparotomy is as high as 20 according to current literature and repair of incisional hernias is one of the most frequently performed operations by general surgeons A not inconsiderable part of these hernias due to their size complexity or degree of contamination is considered complex abdominal wall Surgery in these patients is a major surgery that is accompanied by a marked anabolic response and a high incidence of local and systemic complications and a high recurrence rate
In recent years there has been a growing interest in evaluating the relationship between surgical results and body composition Sarcopenia is a new concept that reflects the loss of skeletal muscle mass Recent publications have recognized sarcopenia as a prognostic factor in the evolution of surgical patients operated on for cancer transplants trauma and emergency surgery but there is still little evidence that it plays a role in surgery for the complex abdominal wall
The prevalence of sarcopenia is growing progressively One of the causes may be that life expectancy has increased worldwide and is well known that ageing is associated with the progressive loss of muscle mass 9
Sarcopenia can be classified into primary which is caused by ageing and secondary which is caused by immobility or diseases such as cancer 10
On the other hand obesity is defined as abnormal or excessive accumulation of fat mass It is a major public health problem and is recognized as a risk factor for global morbidity and mortality Its incidence continues to increase worldwide and its prevalence has doubled since 1980 11 It is well documented that visceral obesity is associated with high complication rates in patients who undergo abdominal wall surgery 12-15
The body mass index BMI has long been used to diagnose malnutrition However weight gain and loss are not reliable indicators of changes in body composition generally men store body fat in the visceral area while women store it mainly subcutaneously Also people tend to lose muscle mass and gain fat as they age Therefore patients with a similar BMI may have a different nutritional status 16
Sarcopenic obesity combines the risks of obesity and sarcopenia and is considered the worst-case scenario 1718
Objectives
The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our population The aim is to evaluate its relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence
Material and methods
A retrospective study on a prospective maintains database of complex abdominal wall surgery of three hospitals
We have decided to select only patients with defects larger than 10 cm from any location W3 of the EHS classification 19 excluding other causes of complex abdominal wall in order to have a more homogeneous sample 2
Study design
In conjunction with the Radiology Department of Ramón y Cajal University Hospital pre-surgical computed tomography CT scans will be reviewed to establish the diagnosis of sarcopenia obesity sarcopenia-obesity or the absence of these normal The CT scans will be reviewed by two trained investigators blinded to postoperative complications and survival In case of disagreement a third investigator will break the tie
The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra L3 To identify muscle tissue the range -29 to 150 in Hounsfield Units HU will be used The L3 region contains the following muscles psoas paraspinal muscles and muscles of the abdominal wall transverse abdominis external and internal obliques rectus abdominis The skeletal muscle mass index will be calculated with the sum of the cross-sectional areas of these muscles cm2 These values will be normalized according to the square of the patients height m2 As a cut-off point for the diagnosis of sarcopenia we will use the values published by Prado et al 524 cm2 m2 in men and 385 cm2 m2 for women
To define obesity we use several indexes The most widely accepted is body mass index BMI 30 kg m2 25-30 kg m2-overweight However this index does not take into account muscle mass and fat distribution which are associated with different risk profiles The Visceral Fat Area VFA measured by CT is strongly correlated with BMI and waist circumference Cross-sectional measurement of VFA demonstrates a stronger correlation than anthropomorphic measurements with obesity-related conditions such as hypertriglyceridaemia hypertension hyperglycemia and low levels of high-density lipoprotein HDL cholesterol The VFA measurement will be performed in a cross-section in the preoperative CT scan at the L3 level To identify fat tissue the range -190 to -30 in Hounsfield Units HU will be used
According to the Japanese Obesity Society we will consider visceral obesity calculated by CT as a visceral fat area VFA 100cm2 regardless of sex and age Despite the fact that the Asian population and the Western population present important differences this data has already been used previously in European series To complete the study the Subcutaneous Fat Area SFA will also be measured With the previous data the VFA SFA ratio will be calculated The patient will be considered viscerally obese when the VFA SFA ratio is 04 This correction will be used to mitigate biases derived from using values in different populations
The study will be completed with the collection of sociodemographic data characteristics of the surgical procedure as well as complications derived from it Likewise the presence or absence of recurrence will be collected
Study variables sex age comorbidities and presence of risk factors for the development of incisional hernia ASA weight height BMI date of surgical intervention size and location of the hernia surgical technique postoperative complications according to Clavien-Dindo stay readmission late complications hernia recurrence end-date of follow-up To evaluate patient-reported outcomes a quality-of-life assessment was measured preoperatively and at 1- and 2-year follow-up using the European Registry for Abdominal Wall Hernias Quality of Life EuraHS-QoL score a hernia-specific tool developed by the European Hernia Society 20 In addition the following will be collected by radiology skeletal muscle mass index Skeletal Muscle Index SMI visceral fat area VFA and subcutaneous fat area SFA
Procedures for collecting clinical data
First patients potentially candidates for the study will be selected from the complex abdominal wall database of the three participating hospitals
Data of selected patients from Hospital Ramón y Cajal will be sent to the Radiology Department of the Ramón y Cajal University Hospital for the collection of SMI VFA and SFA in the pre-surgical CT scan
The preoperative CT scans of the selected patients from the Henares University Hospital and the Puerta de Hierro-Majadahonda University Hospital will be recorded on a computer device to be analyzed in the Radiology Department of the Ramón y Cajal University Hospital Once the study variables have been calculated computing devices containing preoperative CTs will be eliminated
Statistical analysis
The normality of the quantitative variables will be analyzed with the Kolmogorov-Smirnov test Continuous variables will be expressed as mean with standard deviation and categorical variables will be represented as proportions For comparison analysis between groups continuous variables will be compared using the Students t-test and categorical variables will be analyzed as appropriate using the χ2 test or Fishers exact test univariate analysis
For the analysis of hernia recurrence the Kaplan-Meier method will be used In the comparison of hernia recurrence between the groups the long-rank test will be performed In the multivariate analysis for hernia recurrence the Cox regression model will be used which will include the significant variables in the univariate analysis
To evaluate the independent contribution of each variable to the presence of complications a univariate and multivariate logistic regression analysis will be performed with the inclusion of candidate predictors which are significant with p 0200 in the univariate comparison analysis
A statistically significant result will be considered when a value of p 005 SPSS Statistics Version 23 will be used for statistical analysis
Study limitations
Retrospective study
Schedule of activities The approval of the Clinical Research Ethics Committee of the Ramón y Cajal University Hospital is expected to be obtained in January 2021
After this the patients candidates to participate in the study will be selected from the complex abdominal wall data base of the three participating hospitals We estimate that this selection will be made in the month of February
Once the patients have been selected the parameters described in the materials and methods section will be determined in the preoperative CT scan of each patient We estimate that the time required to complete this part of the study will be six to eight months
Next a statistical analysis will be made of the data obtained from the preoperative CT scan and from the complex abdominal wall surgery database and the results will be interpreted A manuscript will be prepared to communicate the results obtained We estimate that this process will be performed in two or three months
Study benefits
To know the incidence of sarcopenia and sarcopenic obesity in complex abdominal wall patients
To confirm whether sarcopenia and sarcopenic obesity are risk factors for the appearance of complications and recurrence after complex abdominal wall surgery
This could help to better estimate the surgical risk of patients undergoing complex abdominal wall surgery
Sarcopenia and sarcopenic obesity are potentially modifiable with a proper nutritional and physical exercise program If we show that sarcopenia and sarcopenic obesity are risk factors for the appearance of complications it could help to reduce the morbidity of these patients
In recent years there has been a growing interest in evaluating the relationship between surgical results and body composition Sarcopenia is a new concept that reflects the loss of skeletal muscle mass Recent publications have recognized sarcopenia as a prognostic factor in the evolution of surgical patients operated on for cancer transplants trauma and emergency surgery but there is still little evidence that it plays a role in surgery for the complex abdominal wall
The prevalence of sarcopenia is growing progressively One of the causes may be that life expectancy has increased worldwide and is well known that ageing is associated with the progressive loss of muscle mass 9
Sarcopenia can be classified into primary which is caused by ageing and secondary which is caused by immobility or diseases such as cancer 10
On the other hand obesity is defined as abnormal or excessive accumulation of fat mass It is a major public health problem and is recognized as a risk factor for global morbidity and mortality Its incidence continues to increase worldwide and its prevalence has doubled since 1980 11 It is well documented that visceral obesity is associated with high complication rates in patients who undergo abdominal wall surgery 12-15
The body mass index BMI has long been used to diagnose malnutrition However weight gain and loss are not reliable indicators of changes in body composition generally men store body fat in the visceral area while women store it mainly subcutaneously Also people tend to lose muscle mass and gain fat as they age Therefore patients with a similar BMI may have a different nutritional status 16
Sarcopenic obesity combines the risks of obesity and sarcopenia and is considered the worst-case scenario 1718
Objectives
The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our population The aim is to evaluate its relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence
Material and methods
A retrospective study on a prospective maintains database of complex abdominal wall surgery of three hospitals
We have decided to select only patients with defects larger than 10 cm from any location W3 of the EHS classification 19 excluding other causes of complex abdominal wall in order to have a more homogeneous sample 2
Study design
In conjunction with the Radiology Department of Ramón y Cajal University Hospital pre-surgical computed tomography CT scans will be reviewed to establish the diagnosis of sarcopenia obesity sarcopenia-obesity or the absence of these normal The CT scans will be reviewed by two trained investigators blinded to postoperative complications and survival In case of disagreement a third investigator will break the tie
The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra L3 To identify muscle tissue the range -29 to 150 in Hounsfield Units HU will be used The L3 region contains the following muscles psoas paraspinal muscles and muscles of the abdominal wall transverse abdominis external and internal obliques rectus abdominis The skeletal muscle mass index will be calculated with the sum of the cross-sectional areas of these muscles cm2 These values will be normalized according to the square of the patients height m2 As a cut-off point for the diagnosis of sarcopenia we will use the values published by Prado et al 524 cm2 m2 in men and 385 cm2 m2 for women
To define obesity we use several indexes The most widely accepted is body mass index BMI 30 kg m2 25-30 kg m2-overweight However this index does not take into account muscle mass and fat distribution which are associated with different risk profiles The Visceral Fat Area VFA measured by CT is strongly correlated with BMI and waist circumference Cross-sectional measurement of VFA demonstrates a stronger correlation than anthropomorphic measurements with obesity-related conditions such as hypertriglyceridaemia hypertension hyperglycemia and low levels of high-density lipoprotein HDL cholesterol The VFA measurement will be performed in a cross-section in the preoperative CT scan at the L3 level To identify fat tissue the range -190 to -30 in Hounsfield Units HU will be used
According to the Japanese Obesity Society we will consider visceral obesity calculated by CT as a visceral fat area VFA 100cm2 regardless of sex and age Despite the fact that the Asian population and the Western population present important differences this data has already been used previously in European series To complete the study the Subcutaneous Fat Area SFA will also be measured With the previous data the VFA SFA ratio will be calculated The patient will be considered viscerally obese when the VFA SFA ratio is 04 This correction will be used to mitigate biases derived from using values in different populations
The study will be completed with the collection of sociodemographic data characteristics of the surgical procedure as well as complications derived from it Likewise the presence or absence of recurrence will be collected
Study variables sex age comorbidities and presence of risk factors for the development of incisional hernia ASA weight height BMI date of surgical intervention size and location of the hernia surgical technique postoperative complications according to Clavien-Dindo stay readmission late complications hernia recurrence end-date of follow-up To evaluate patient-reported outcomes a quality-of-life assessment was measured preoperatively and at 1- and 2-year follow-up using the European Registry for Abdominal Wall Hernias Quality of Life EuraHS-QoL score a hernia-specific tool developed by the European Hernia Society 20 In addition the following will be collected by radiology skeletal muscle mass index Skeletal Muscle Index SMI visceral fat area VFA and subcutaneous fat area SFA
Procedures for collecting clinical data
First patients potentially candidates for the study will be selected from the complex abdominal wall database of the three participating hospitals
Data of selected patients from Hospital Ramón y Cajal will be sent to the Radiology Department of the Ramón y Cajal University Hospital for the collection of SMI VFA and SFA in the pre-surgical CT scan
The preoperative CT scans of the selected patients from the Henares University Hospital and the Puerta de Hierro-Majadahonda University Hospital will be recorded on a computer device to be analyzed in the Radiology Department of the Ramón y Cajal University Hospital Once the study variables have been calculated computing devices containing preoperative CTs will be eliminated
Statistical analysis
The normality of the quantitative variables will be analyzed with the Kolmogorov-Smirnov test Continuous variables will be expressed as mean with standard deviation and categorical variables will be represented as proportions For comparison analysis between groups continuous variables will be compared using the Students t-test and categorical variables will be analyzed as appropriate using the χ2 test or Fishers exact test univariate analysis
For the analysis of hernia recurrence the Kaplan-Meier method will be used In the comparison of hernia recurrence between the groups the long-rank test will be performed In the multivariate analysis for hernia recurrence the Cox regression model will be used which will include the significant variables in the univariate analysis
To evaluate the independent contribution of each variable to the presence of complications a univariate and multivariate logistic regression analysis will be performed with the inclusion of candidate predictors which are significant with p 0200 in the univariate comparison analysis
A statistically significant result will be considered when a value of p 005 SPSS Statistics Version 23 will be used for statistical analysis
Study limitations
Retrospective study
Schedule of activities The approval of the Clinical Research Ethics Committee of the Ramón y Cajal University Hospital is expected to be obtained in January 2021
After this the patients candidates to participate in the study will be selected from the complex abdominal wall data base of the three participating hospitals We estimate that this selection will be made in the month of February
Once the patients have been selected the parameters described in the materials and methods section will be determined in the preoperative CT scan of each patient We estimate that the time required to complete this part of the study will be six to eight months
Next a statistical analysis will be made of the data obtained from the preoperative CT scan and from the complex abdominal wall surgery database and the results will be interpreted A manuscript will be prepared to communicate the results obtained We estimate that this process will be performed in two or three months
Study benefits
To know the incidence of sarcopenia and sarcopenic obesity in complex abdominal wall patients
To confirm whether sarcopenia and sarcopenic obesity are risk factors for the appearance of complications and recurrence after complex abdominal wall surgery
This could help to better estimate the surgical risk of patients undergoing complex abdominal wall surgery
Sarcopenia and sarcopenic obesity are potentially modifiable with a proper nutritional and physical exercise program If we show that sarcopenia and sarcopenic obesity are risk factors for the appearance of complications it could help to reduce the morbidity of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None