SarcopeniaNCT04690179
Effects of Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery
An observational study of Sarcopenia and Sarcopenic Obesity, run by Hospital Universitario Ramon y Cajal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Sarcopenic Obesity, Incisional Hernia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2021to 15 Oct 2021
- 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 undergoing complex abdominal wall surgery at the Ramón y Cajal University Hospital, at the Puerta de Hierro-Majadahona University Hospital and at the Henares University Hospital
Who may be able to join
- Patients operated for an incisional hernia with a transverse diameter greater than 10 cm measured in the preoperative Computed Tomography.
Who cannot join
- Not having a preoperative Computed Tomography performed in the three months before the operation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery: Postoperative Complications and Their Impact on Recurrence
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.
Read more
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.
Read the 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 (17,18).
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 patient's height (m2). As a cut-off point for the diagnosis of sarcopenia, we will use the values published by Prado et al. (≤52.4 cm2 / m2 in men and ≤38.5 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 <0.4. 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 Student's t-test and categorical variables will be analyzed, as appropriate, using the χ2 test or Fisher's 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 <0.200 in the univariate comparison analysis.
A statistically significant result will be considered when a value of p <0.05. 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.
- Conditions
- Sarcopenia, Sarcopenic Obesity, Incisional Hernia
- Medical subject headings
- Sarcopenia, Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Presence of local or systemic complications
Measured: Thirty postoperative day
Recurrence
Appearance of an incisional hernia recurrence
Measured: Twenty four postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start18 Jan 2021 (estimated)
- Primary completion15 Aug 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Blázquez Hernando, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690179
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2020
- First submitted
- 26 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romain B, Renard Y, Binquet C, Poghosyan T, Moszkowicz D, Gillion JF, Ortega-Deballon P; Participating surgeons' list. Recurrence after elective incisional hernia repair is more frequent than you think: An international prospective cohort from the French Society of Surgery. Surgery. 2020 Jul;168(1):125-134. doi: 10.1016/j.surg.2020.02.016. Epub 2020 Apr 15.
PubMed 32305229Slater NJ, Montgomery A, Berrevoet F, Carbonell AM, Chang A, Franklin M, Kercher KW, Lammers BJ, Parra-Davilla E, Roll S, Towfigh S, van Geffen E, Conze J, van Goor H. Criteria for definition of a complex abdominal wall hernia. Hernia. 2014 Feb;18(1):7-17. doi: 10.1007/s10029-013-1168-6. Epub 2013 Oct 23.
PubMed 24150721Garcia-Urena MA, Lopez-Monclus J, Cuccurullo D, Blazquez Hernando LA, Garcia-Pastor P, Reggio S, Jimenez Cubedo E, San Miguel Mendez C, Cruz Cidoncha A, Robin Valle de Lersundi A. Abdominal Wall Reconstruction Utilizing the Combination of Absorbable and Permanent Mesh in a Retromuscular Position: A Multicenter Prospective Study. World J Surg. 2019 Jan;43(1):149-158. doi: 10.1007/s00268-018-4765-9.
PubMed 30132226Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25.
PubMed 26407875Peng P, Hyder O, Firoozmand A, Kneuertz P, Schulick RD, Huang D, Makary M, Hirose K, Edil B, Choti MA, Herman J, Cameron JL, Wolfgang CL, Pawlik TM. Impact of sarcopenia on outcomes following resection of pancreatic adenocarcinoma. J Gastrointest Surg. 2012 Aug;16(8):1478-86. doi: 10.1007/s11605-012-1923-5. Epub 2012 Jun 13.
PubMed 22692586Englesbe MJ, Lee JS, He K, Fan L, Schaubel DE, Sheetz KH, Harbaugh CM, Holcombe SA, Campbell DA Jr, Sonnenday CJ, Wang SC. Analytic morphomics, core muscle size, and surgical outcomes. Ann Surg. 2012 Aug;256(2):255-61. doi: 10.1097/SLA.0b013e31826028b1.
PubMed 22791101Lee JS, He K, Harbaugh CM, Schaubel DE, Sonnenday CJ, Wang SC, Englesbe MJ, Eliason JL; Michigan Analytic Morphomics Group (MAMG). Frailty, core muscle size, and mortality in patients undergoing open abdominal aortic aneurysm repair. J Vasc Surg. 2011 Apr;53(4):912-7. doi: 10.1016/j.jvs.2010.10.111. Epub 2011 Jan 7.
PubMed 21215580Englesbe MJ, Patel SP, He K, Lynch RJ, Schaubel DE, Harbaugh C, Holcombe SA, Wang SC, Segev DL, Sonnenday CJ. Sarcopenia and mortality after liver transplantation. J Am Coll Surg. 2010 Aug;211(2):271-8. doi: 10.1016/j.jamcollsurg.2010.03.039. Epub 2010 Jun 26.
PubMed 20670867Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet. 2009 Oct 3;374(9696):1196-208. doi: 10.1016/S0140-6736(09)61460-4.
PubMed 19801098Santilli V, Bernetti A, Mangone M, Paoloni M. Clinical definition of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):177-80.
PubMed 25568649Wannamethee SG, Atkins JL. Muscle loss and obesity: the health implications of sarcopenia and sarcopenic obesity. Proc Nutr Soc. 2015 Nov;74(4):405-12. doi: 10.1017/S002966511500169X. Epub 2015 Apr 27.
PubMed 25913270Nakayama M, Yoshimatsu K, Yokomizo H, Yano Y, Okayama S, Satake M, Matsumoto A, Fujimoto T, Usui T, Yamaguchi K, Shiozawa S, Shimakawa T, Katsube T, Naritaka Y. Incidence and risk factors for incisional hernia after open surgery for colorectal cancer. Hepatogastroenterology. 2014 Jul-Aug;61(133):1220-3.
PubMed 25436286Krpata DM, Blatnik JA, Novitsky YW, Rosen MJ. Evaluation of high-risk, comorbid patients undergoing open ventral hernia repair with synthetic mesh. Surgery. 2013 Jan;153(1):120-5. doi: 10.1016/j.surg.2012.06.003. Epub 2012 Aug 3.
PubMed 22862901Itatsu K, Yokoyama Y, Sugawara G, Kubota H, Tojima Y, Kurumiya Y, Kono H, Yamamoto H, Ando M, Nagino M. Incidence of and risk factors for incisional hernia after abdominal surgery. Br J Surg. 2014 Oct;101(11):1439-47. doi: 10.1002/bjs.9600. Epub 2014 Aug 14.
PubMed 25123379Aquina CT, Rickles AS, Probst CP, Kelly KN, Deeb AP, Monson JR, Fleming FJ; Muscle and Adiposity Research Consortium (MARC). Visceral obesity, not elevated BMI, is strongly associated with incisional hernia after colorectal surgery. Dis Colon Rectum. 2015 Feb;58(2):220-7. doi: 10.1097/DCR.0000000000000261.
PubMed 25585081
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery: Postoperative Complications and Their Impact on Recurrence
- ClinicalTrials.gov ID
- NCT04690179
- Acronym / sponsor ID
- 1
- Conditions
- Sarcopenia, Sarcopenic Obesity, Incisional Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 18 Jan 2021 (estimated)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 30 Dec 2020 (actual)
- 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.
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.
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 (17,18).
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 patient's height (m2). As a cut-off point for the diagnosis of sarcopenia, we will use the values published by Prado et al. (≤52.4 cm2 / m2 in men and ≤38.5 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 <0.4. 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 Student's t-test and categorical variables will be analyzed, as appropriate, using the χ2 test or Fisher's 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 <0.200 in the univariate comparison analysis.
A statistically significant result will be considered when a value of p <0.05. 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing complex abdominal wall surgery at the Ramón y Cajal University Hospital, at the Puerta de Hierro-Majadahona University Hospital and at the Henares University Hospital
Key inclusion criteria (1 listed)
- Patients operated for an incisional hernia with a transverse diameter greater than 10 cm measured in the preoperative Computed Tomography.
Key exclusion criteria (1 listed)
- Not having a preoperative Computed Tomography performed in the three months before the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: Thirty postoperative day
Presence of local or systemic complications
Recurrence
Time frame: Twenty four postoperative month
Appearance of an incisional hernia recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Background: PubMed 32305229Romain B, Renard Y, Binquet C, Poghosyan T, Moszkowicz D, Gillion JF, Ortega-Deballon P; Participating surgeons' list. Recurrence after elective incisional hernia repair is more frequent than you think: An international prospective cohort from the French Society of Surgery. Surgery. 2020 Jul;168(1):125-134. doi: 10.1016/j.surg.2020.02.016. Epub 2020 Apr 15.
- Background: PubMed 24150721Slater NJ, Montgomery A, Berrevoet F, Carbonell AM, Chang A, Franklin M, Kercher KW, Lammers BJ, Parra-Davilla E, Roll S, Towfigh S, van Geffen E, Conze J, van Goor H. Criteria for definition of a complex abdominal wall hernia. Hernia. 2014 Feb;18(1):7-17. doi: 10.1007/s10029-013-1168-6. Epub 2013 Oct 23.
- Background: PubMed 30132226Garcia-Urena MA, Lopez-Monclus J, Cuccurullo D, Blazquez Hernando LA, Garcia-Pastor P, Reggio S, Jimenez Cubedo E, San Miguel Mendez C, Cruz Cidoncha A, Robin Valle de Lersundi A. Abdominal Wall Reconstruction Utilizing the Combination of Absorbable and Permanent Mesh in a Retromuscular Position: A Multicenter Prospective Study. World J Surg. 2019 Jan;43(1):149-158. doi: 10.1007/s00268-018-4765-9.
- Background: PubMed 26407875Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25.
- Background: PubMed 22692586Peng P, Hyder O, Firoozmand A, Kneuertz P, Schulick RD, Huang D, Makary M, Hirose K, Edil B, Choti MA, Herman J, Cameron JL, Wolfgang CL, Pawlik TM. Impact of sarcopenia on outcomes following resection of pancreatic adenocarcinoma. J Gastrointest Surg. 2012 Aug;16(8):1478-86. doi: 10.1007/s11605-012-1923-5. Epub 2012 Jun 13.
- Background: PubMed 22791101Englesbe MJ, Lee JS, He K, Fan L, Schaubel DE, Sheetz KH, Harbaugh CM, Holcombe SA, Campbell DA Jr, Sonnenday CJ, Wang SC. Analytic morphomics, core muscle size, and surgical outcomes. Ann Surg. 2012 Aug;256(2):255-61. doi: 10.1097/SLA.0b013e31826028b1.
- Background: PubMed 21215580Lee JS, He K, Harbaugh CM, Schaubel DE, Sonnenday CJ, Wang SC, Englesbe MJ, Eliason JL; Michigan Analytic Morphomics Group (MAMG). Frailty, core muscle size, and mortality in patients undergoing open abdominal aortic aneurysm repair. J Vasc Surg. 2011 Apr;53(4):912-7. doi: 10.1016/j.jvs.2010.10.111. Epub 2011 Jan 7.
- Background: PubMed 20670867Englesbe MJ, Patel SP, He K, Lynch RJ, Schaubel DE, Harbaugh C, Holcombe SA, Wang SC, Segev DL, Sonnenday CJ. Sarcopenia and mortality after liver transplantation. J Am Coll Surg. 2010 Aug;211(2):271-8. doi: 10.1016/j.jamcollsurg.2010.03.039. Epub 2010 Jun 26.
- Background: PubMed 19801098Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet. 2009 Oct 3;374(9696):1196-208. doi: 10.1016/S0140-6736(09)61460-4.
- Background: PubMed 25568649Santilli V, Bernetti A, Mangone M, Paoloni M. Clinical definition of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):177-80.
- Background: PubMed 25913270Wannamethee SG, Atkins JL. Muscle loss and obesity: the health implications of sarcopenia and sarcopenic obesity. Proc Nutr Soc. 2015 Nov;74(4):405-12. doi: 10.1017/S002966511500169X. Epub 2015 Apr 27.
- Background: PubMed 25436286Nakayama M, Yoshimatsu K, Yokomizo H, Yano Y, Okayama S, Satake M, Matsumoto A, Fujimoto T, Usui T, Yamaguchi K, Shiozawa S, Shimakawa T, Katsube T, Naritaka Y. Incidence and risk factors for incisional hernia after open surgery for colorectal cancer. Hepatogastroenterology. 2014 Jul-Aug;61(133):1220-3.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Sarcopenic Obesity, run by Hospital Universitario Ramon y Cajal.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Blázquez Hernando, MD (+34 606986114, luisalberto.blazquez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Thirty postoperative day). 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?
On the ClinicalTrials.gov record for NCT04690179, which also lists 19 linked publications.
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 30 Dec 2020.