Hernia IncisionalRTLNCT04134455
The Mesh-RTL Project, for Prevention of Incisional Hernia
A study testing Mesh reinforcement and RTL reinforcement in people with Hernia Incisional, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
Trial summary
Introduction: By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia Incisional
- What is being tested?
- Mesh reinforcement and RTL reinforcement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jan 2022to 4 Feb 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years undergoing midline laparotomy, independently of diagnostic or condition, elective or emergency surgery
- Patients with a score equal or greater than 7 of the hernia score
- Patients who accept to participate and sign the informed consent
Who cannot join
- Patients managed with open abdomen or with the impossibility of close the wall
- Patients who had a previous incisional hernia or patients who are participing in anohter trial
- Patients with a life expectative less than 12 months
- Pregnant patients Patients with the antecedent of rejection of prosthesic material
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital regional de Alta Especialidad del bajio
León, Guanajuato, 37660
About this study
Official title: The Mesh-RTL Project for Prevention of Incisional Hernia: Clinical Trial of Non-inferiority to Compare Two Aponeurotic Closure Techniques in Midline Laparotomy in Patients With Elevated Risk for Hernia
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures. The objective of this study is to determine if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.
Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out with intent to treat and not inferiority with 95% confidence intervals
Read the detailed description
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs.
It is classified according to the medical indication: exploratory, therapeutic, stagemaker, and recently added "damage-control" laparotomy.
There exists so many ways to access the abdominal cavity, usually in relation with the organ or structure to treat; being classified in midline laparotomy, paramedian, transversal, oblique, abdominal-thoracic, etc.
Either an emergency or scheduled procedure, the more usual and functional continues being the midline laparotomy, since it allows a broader and faster approach, with less bleeding and easily to extend if it becomes necessary.
Both the evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures.
So far only the use of the mesh has proven useful in reducing this complication. The authors published in 2016 a clinical trial where it showed that the technique is safe and effective to reduce the presence of incisional hernia, however the use of the mesh brings with it problems such as cost, possibility and use in contaminated cavities and postoperative pain. Therefore, the use of the RTL technique as an alternative means to this will help to have one more option for the management of patients with a high risk of incisional hernia.
Problem Statement:
Does the RTL closing technique in the midline laparotomy has the same incident of herniation than the close with supraaponeurotic mesh in patient with elevated risk?
Justification The presence of postincisional hernia need to be considerate as a serious disease, insomuch as it carry on highs rates of morbimortality. The presence of this eventuality is among 0.4-1.2% in elective surgery and up to 30% in emergency procedures.
It is calculated in de U.S.A. an approximate of 1 million of reinterventions a year to correct this condition, with the respective monetary, time and suffering cost to the patient and the health system.
Given the seriousness, the ultimate global consensus has determinate three main axes to the surgical community to board:
- Identify the relevance of the problem
- Improve the theoretical knowledge and technical capacity in the closing of the abdominal wall
- Implement prophylactic measures in the patients, especially in those with elevated risk.
With the present study the authors aim to contribute to this global recommendations, comparing two closing techniques of the abdominal wall after a midline laparotomy in patients with elevated risk of herniation. Both techniques are proved safe and useful in other studies, with no comparison to date.
Demonstrate that the use of RTL technique has a similar incidence of herniation than the mesh, in an attempt to prevent postincisional hernias after a midline laparotomy, will bring to the surgical community a cheaper and practical alternative to the mesh.
Objectives:
General:
To determinate if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.
Specifics:
- To identify the patients with high risk using de validated HERNIA-Project Score.
- To determinate the incidence of post-incisional hernia after one year of the initial midline laparotomy.
- To compare the incidence of post-incisional hernia between the two groups.
- To describe the complications related to each closure technique.
Hypothesis:
Ho Hypothesis:
There is no difference in the incidence of post-incisional hernia between the RTL technique and the reinforcement with supraaponeurotic mesh closure wall.
H1 Hypothesis:
There is difference in the incidence of post-incisional hernia between the RTL technique and the reinforcement with supraaponeurotic mesh closure wall.
Sample size:
The sample size was calculated according to the formula published by Bouemn et all 2015, and based on the results of Kholer and collaborators 2019, where the authors found in which a percentage of success was estimated with the standard treatment of 7% compared to the experimental management of 11%, with a margin of no less than 5%, with an alpha for a tail of 0.05%, and a beta of 20 %, a total of 125 patients per group was obtained.
Statistical analysis:
Categorical values will be present as frequency and percentage, comparisons between groups will be done using the χ2 test for binary data or Fisher´s exact test. Continuous variables will be presented as means (SDs) or median and range interquartile range, if they meet normal criteria and will be compared using the Mann-Whitney U-test or t student test. p-Values of less than 0.05 will be considered significant. Statistical analyses will be performed using SPSS statistical software, version 25.0.0 (IBM corp). Analysis by intention to treat will be used. A Kaplan-Meier curve of the occurrence of incisional hernias stratified by treatment group will be plotted, and a long-rank test will be used to compare the hernia incidence between the groups
- Conditions
- Hernia Incisional
- Being tested
- Mesh reinforcement, RTL reinforcement
- Keywords
- Mesh, RTL(reinforced tension line), Prevention, Prophylactic Mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh reinforcementProcedure or surgery
Also called Prophylactic Mesh reinforcement
Once the surgery is over. The closure is made with the 4: 1 rule, then an onlay mesh is placed that exceeds 3 cm on each side the wound is fixed with suture.
RTL reinforcementProcedure or surgery
Also called Technique RTL
Once the surgery is finished, the ared is reinforced by placing a longitudinal suture parallel to the edge of the wound 0.5 cm, then the wound is closed with a 4: 1 rule but the suture enters lateral to the reinforcement suture
| Study group | Role | What they receive |
|---|---|---|
| Onlay Mesh Reinforcement group | Active comparator | The midline fascia was closed with running, slowly absorbable sutures (PDS 1-0) with a recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 cm was created between the anterior fascia and the subcutis. A Lightweight polypropylene mesh was used and placed on the anterior rectus fascia with an overlap of 3 cm. The mesh was fitted in the dissected space and it was fixed with PDS 2-0 suture. Fixing points are placed taking the mesh and the anterior fascia of the rectus muscle, at a distance of 3 cm between each point until completing its circunference. Receives: Procedure: Mesh reinforcement |
| RTL reinforcement group | Experimental | The RTL suture is placed parallel at a distance of 0.5 cm from the fascial margin. Ideally the thread should lie between the anterior and the posterior rectus muscle sheath; there should be no contact with the rectus muscle. A nonabsorbable monofilamental polypropylene thread and a 65-mm ½ needle are used. Around this longitudinal thread, the continuous suture for fascial closure is introduced immediately lateral to the thread; with running, slowly absorbable sutures (PDS 1-0) with a recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 cm was created between the anterior fascia and the subcutis Receives: Procedure: RTL reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute incisional hernia
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Measured: 30 days
Number of participants with Incisional hernia
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Measured: 1 year
Number of participants with Incisional hernia
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Measured: 3 years
Secondary outcomes (3)
Number of participants with surgical site infection
Includes at least one of the following: (a) purulent drainage is present (culture documentation not required); (b) organisms are isolated from fluid/tissue of the superficial incision; (c) at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present; (d) the wound is deliberately opened by the surgeon; (e) the surgeon or clinician declares the wound infected
Measured: 30 days
abdominal pain postoperative
It will be measured according to the visual analogue scale. Scale whose score goes from 0-10 being ten the maximum level expressed by the patient.
Measured: 5 days postoperative
Number of participants with seroma
presence of accumulation of clear body fluids in a place where the tissue has been removed by surgery, not associated with infection
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start20 Jan 2022
- Primary completion30 Jan 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Hernia IncisionalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial of non-inferiority
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edgard Lozada, Hospital Regional de Alta Especialidad del Bajio
- Investigators
- Jose de Jesus Alvarez Canales, Dr, Study director, Hospital Regional de Alta Especialidad del Bajio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134455
- Sponsor's protocol ID
- CI/HRAEB/2018/08
- Other IDs
- MeshVsRTL
- Acronym
- RTL
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database available for analysis
Publications
Medina Ramírez O, Martínez Munive A. Hernias recurrentes y eventración posoperatoria. En: Consejo Mexicano de Cirugía General. Tratado de Cirugía General. Editorial Manual Moderno. México DF. 2009. p. 263-288
Pelissier E, Armstrong O, Ngo P. Anatomía quirúrgica y vías de acceso del abdomen. EMC Elsevier Masson, Paris. 2011; 40-040: 1-40.
Shell DH 4th, de la Torre J, Andrades P, Vasconez LO. Open repair of ventral incisional hernias. Surg Clin North Am. 2008 Feb;88(1):61-83, viii. doi: 10.1016/j.suc.2007.10.008.
PubMed 18267162van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
PubMed 15098775Ramirez Barba EJ, Lozano R, Lara Lona E. Epidemiologia de las hernias de la pared abdominal. En: Mayagoitia González JC, hernias de la pared abdominal. Tratamiento actual. 2 ed. Mexico; Editorial Alfil; 2009. p 9-11.
Halm JA, Lip H, Schmitz PI, Jeekel J. Incisional hernia after upper abdominal surgery: a randomised controlled trial of midline versus transverse incision. Hernia. 2009 Jun;13(3):275-80. doi: 10.1007/s10029-008-0469-7. Epub 2009 Mar 4.
PubMed 19259615Le Huu Nho R, Mege D, Ouaissi M, Sielezneff I, Sastre B. Incidence and prevention of ventral incisional hernia. J Visc Surg. 2012 Oct;149(5 Suppl):e3-14. doi: 10.1016/j.jviscsurg.2012.05.004. Epub 2012 Nov 9.
PubMed 23142402Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.
PubMed 12643854van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.
PubMed 19898894Gómez CJ, Pere RC. Validación de un modelo de evisceración. Cir Esp. 2013. http://dx.doi.org/10.1016/j.ciresp.2012.12.0088
Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.
PubMed 25690673Cherla DV, Moses ML, Mueck KM, Hannon C, Ko TC, Kao LS, Liang MK. External Validation of the HERNIAscore: An Observational Study. J Am Coll Surg. 2017 Sep;225(3):428-434. doi: 10.1016/j.jamcollsurg.2017.05.010. Epub 2017 May 26.
PubMed 28554782Marwah S, Marwah N, Singh M, Kapoor A, Karwasra RK. Addition of rectus sheath relaxation incisions to emergency midline laparotomy for peritonitis to prevent fascial dehiscence. World J Surg. 2005 Feb;29(2):235-9. doi: 10.1007/s00268-004-7538-6.
PubMed 15654663Niggebrugge AH, Trimbos JB, Hermans J, Steup WH, Van De Velde CJ. Influence of abdominal-wound closure technique on complications after surgery: a randomised study. Lancet. 1999 May 8;353(9164):1563-7. doi: 10.1016/S0140-6736(98)10181-2.
PubMed 10334254Abbott DE, Dumanian GA, Halverson AL. Management of laparotomy wound dehiscence. Am Surg. 2007 Dec;73(12):1224-7.
PubMed 18186376
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mesh-RTL Project for Prevention of Incisional Hernia: Clinical Trial of Non-inferiority to Compare Two Aponeurotic Closure Techniques in Midline Laparotomy in Patients With Elevated Risk for Hernia
- ClinicalTrials.gov ID
- NCT04134455
- Acronym / sponsor ID
- RTL / CI/HRAEB/2018/08
- Conditions
- Hernia Incisional
- Keywords
- Mesh, RTL(reinforced tension line), Prevention, Prophylactic Mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 22 Oct 2019 (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.
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures. The objective of this study is to determine if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.
Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out with intent to treat and not inferiority with 95% confidence intervals
Detailed description
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs.
It is classified according to the medical indication: exploratory, therapeutic, stagemaker, and recently added "damage-control" laparotomy.
There exists so many ways to access the abdominal cavity, usually in relation with the organ or structure to treat; being classified in midline laparotomy, paramedian, transversal, oblique, abdominal-thoracic, etc.
Either an emergency or scheduled procedure, the more usual and functional continues being the midline laparotomy, since it allows a broader and faster approach, with less bleeding and easily to extend if it becomes necessary.
Both the evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures.
So far only the use of the mesh has proven useful in reducing this complication. The authors published in 2016 a clinical trial where it showed that the technique is safe and effective to reduce the presence of incisional hernia, however the use of the mesh brings with it problems such as cost, possibility and use in contaminated cavities and postoperative pain. Therefore, the use of the RTL technique as an alternative means to this will help to have one more option for the management of patients with a high risk of incisional hernia.
Problem Statement:
Does the RTL closing technique in the midline laparotomy has the same incident of herniation than the close with supraaponeurotic mesh in patient with elevated risk?
Justification The presence of postincisional hernia need to be considerate as a serious disease, insomuch as it carry on highs rates of morbimortality. The presence of this eventuality is among 0.4-1.2% in elective surgery and up to 30% in emergency procedures.
It is calculated in de U.S.A. an approximate of 1 million of reinterventions a year to correct this condition, with the respective monetary, time and suffering cost to the patient and the health system.
Given the seriousness, the ultimate global consensus has determinate three main axes to the surgical community to board:
- Identify the relevance of the problem
- Improve the theoretical knowledge and technical capacity in the closing of the abdominal wall
- Implement prophylactic measures in the patients, especially in those with elevated risk.
With the present study the authors aim to contribute to this global recommendations, comparing two closing techniques of the abdominal wall after a midline laparotomy in patients with elevated risk of herniation. Both techniques are proved safe and useful in other studies, with no comparison to date.
Demonstrate that the use of RTL technique has a similar incidence of herniation than the mesh, in an attempt to prevent postincisional hernias after a midline laparotomy, will bring to the surgical community a cheaper and practical alternative to the mesh.
Objectives:
General:
To determinate if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.
Specifics:
- To identify the patients with high risk using de validated HERNIA-Project Score.
- To determinate the incidence of post-incisional hernia after one year of the initial midline laparotomy.
- To compare the incidence of post-incisional hernia between the two groups.
- To describe the complications related to each closure technique.
Hypothesis:
Ho Hypothesis:
There is no difference in the incidence of post-incisional hernia between the RTL technique and the reinforcement with supraaponeurotic mesh closure wall.
H1 Hypothesis:
There is difference in the incidence of post-incisional hernia between the RTL technique and the reinforcement with supraaponeurotic mesh closure wall.
Sample size:
The sample size was calculated according to the formula published by Bouemn et all 2015, and based on the results of Kholer and collaborators 2019, where the authors found in which a percentage of success was estimated with the standard treatment of 7% compared to the experimental management of 11%, with a margin of no less than 5%, with an alpha for a tail of 0.05%, and a beta of 20 %, a total of 125 patients per group was obtained.
Statistical analysis:
Categorical values will be present as frequency and percentage, comparisons between groups will be done using the χ2 test for binary data or Fisher´s exact test. Continuous variables will be presented as means (SDs) or median and range interquartile range, if they meet normal criteria and will be compared using the Mann-Whitney U-test or t student test. p-Values of less than 0.05 will be considered significant. Statistical analyses will be performed using SPSS statistical software, version 25.0.0 (IBM corp). Analysis by intention to treat will be used. A Kaplan-Meier curve of the occurrence of incisional hernias stratified by treatment group will be plotted, and a long-rank test will be used to compare the hernia incidence between the groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial of non-inferiority
| Arm | Type | Receives |
|---|---|---|
| Onlay Mesh Reinforcement group | Active comparator | Procedure: Mesh reinforcementThe midline fascia was closed with running, slowly absorbable sutures (PDS 1-0) with a recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 cm was created between the anterior fascia and the subcutis. A Lightweight polypropylene mesh was used and placed on the anterior rectus fascia with an overlap of 3 cm. The mesh was fitted in the dissected space and it was fixed with PDS 2-0 suture. Fixing points are placed taking the mesh and the anterior fascia of the rectus muscle, at a distance of 3 cm between each point until completing its circunference. |
| RTL reinforcement group | Experimental | Procedure: RTL reinforcementThe RTL suture is placed parallel at a distance of 0.5 cm from the fascial margin. Ideally the thread should lie between the anterior and the posterior rectus muscle sheath; there should be no contact with the rectus muscle. A nonabsorbable monofilamental polypropylene thread and a 65-mm ½ needle are used. Around this longitudinal thread, the continuous suture for fascial closure is introduced immediately lateral to the thread; with running, slowly absorbable sutures (PDS 1-0) with a recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 cm was created between the anterior fascia and the subcutis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years undergoing midline laparotomy, independently of diagnostic or condition, elective or emergency surgery
- Patients with a score equal or greater than 7 of the hernia score
- Patients who accept to participate and sign the informed consent
Key exclusion criteria (4 listed)
- Patients managed with open abdomen or with the impossibility of close the wall
- Patients who had a previous incisional hernia or patients who are participing in anohter trial
- Patients with a life expectative less than 12 months
- Pregnant patients Patients with the antecedent of rejection of prosthesic material
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 |
|---|---|---|
| Mesh reinforcementAlso: Prophylactic Mesh reinforcementOnce the surgery is over. The closure is made with the 4: 1 rule, then an onlay mesh is placed that exceeds 3 cm on each side the wound is fixed with suture. | Procedure or surgery | Onlay Mesh Reinforcement group |
| RTL reinforcementAlso: Technique RTLOnce the surgery is finished, the ared is reinforced by placing a longitudinal suture parallel to the edge of the wound 0.5 cm, then the wound is closed with a 4: 1 rule but the suture enters lateral to the reinforcement suture | Procedure or surgery | RTL reinforcement group |
Primary outcome
Number of participants with acute incisional hernia
Time frame: 30 days
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Number of participants with Incisional hernia
Time frame: 1 year
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Number of participants with Incisional hernia
Time frame: 3 years
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
3 secondary outcomes
Number of participants with surgical site infection
Time frame: 30 days
abdominal pain postoperative
Time frame: 5 days postoperative
Number of participants with seroma
Time frame: 10 days
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 28 Feb 2022.
- BackgroundMedina Ramírez O, Martínez Munive A. Hernias recurrentes y eventración posoperatoria. En: Consejo Mexicano de Cirugía General. Tratado de Cirugía General. Editorial Manual Moderno. México DF. 2009. p. 263-288
- BackgroundPelissier E, Armstrong O, Ngo P. Anatomía quirúrgica y vías de acceso del abdomen. EMC Elsevier Masson, Paris. 2011; 40-040: 1-40.
- Background: PubMed 18267162Shell DH 4th, de la Torre J, Andrades P, Vasconez LO. Open repair of ventral incisional hernias. Surg Clin North Am. 2008 Feb;88(1):61-83, viii. doi: 10.1016/j.suc.2007.10.008.
- Background: PubMed 15098775van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
- BackgroundRamirez Barba EJ, Lozano R, Lara Lona E. Epidemiologia de las hernias de la pared abdominal. En: Mayagoitia González JC, hernias de la pared abdominal. Tratamiento actual. 2 ed. Mexico; Editorial Alfil; 2009. p 9-11.
- Background: PubMed 19259615Halm JA, Lip H, Schmitz PI, Jeekel J. Incisional hernia after upper abdominal surgery: a randomised controlled trial of midline versus transverse incision. Hernia. 2009 Jun;13(3):275-80. doi: 10.1007/s10029-008-0469-7. Epub 2009 Mar 4.
- Background: PubMed 23142402Le Huu Nho R, Mege D, Ouaissi M, Sielezneff I, Sastre B. Incidence and prevention of ventral incisional hernia. J Visc Surg. 2012 Oct;149(5 Suppl):e3-14. doi: 10.1016/j.jviscsurg.2012.05.004. Epub 2012 Nov 9.
- Background: PubMed 12643854Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.
- Background: PubMed 19898894van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.
- BackgroundGómez CJ, Pere RC. Validación de un modelo de evisceración. Cir Esp. 2013. http://dx.doi.org/10.1016/j.ciresp.2012.12.0088
- Background: PubMed 25690673Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.
- Background: PubMed 28554782Cherla DV, Moses ML, Mueck KM, Hannon C, Ko TC, Kao LS, Liang MK. External Validation of the HERNIAscore: An Observational Study. J Am Coll Surg. 2017 Sep;225(3):428-434. doi: 10.1016/j.jamcollsurg.2017.05.010. Epub 2017 May 26.
- Individual participant dataSharing planned: Yes. Database available for analysis
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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.
Jose de Jesus Alvarez Canales, Dr study director
Hospital Regional de Alta Especialidad del Bajio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh reinforcement and RTL reinforcement in people with Hernia Incisional, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
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 3 inclusion and 4 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of participants with acute incisional hernia (time frame: 30 days). The study lists 3 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 NCT04134455, which also lists 25 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 28 Feb 2022.