The Mesh-RTL Project, for Prevention of Incisional Hernia

Hernia Incisional Clinical Trial

— RTL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134455
• Other study ID #: CI/HRAEB/2018/08
• Secondary ID: MeshVsRTL
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2022
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 4, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Incisional Hernia

Intervention

Procedure:
• 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 reinforcement
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

Locations

Country	Name	City	State
Mexico	Hospital regional de Alta Especialidad del bajio	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio

Country where clinical trial is conducted

Mexico, 

References & Publications (24)

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Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 Aug;17(4):445-55. doi: 10.1007/s10029-013-1119-2. Epub 2013 May 28. Review. — View Citation

Bouman AC, ten Cate-Hoek AJ, Ramaekers BL, Joore MA. Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach. PLoS One. 2015 Jun 15;10(6):e0130531. doi: 10.1371/journal.pone.0130531. eCollection 2015. — View Citation

Caro-Tarrago A, Olona Casas C, Jimenez Salido A, Duque Guilera E, Moreno Fernandez F, Vicente Guillen V. Prevention of incisional hernia in midline laparotomy with an onlay mesh: a randomized clinical trial. World J Surg. 2014 Sep;38(9):2223-30. doi: 10.1007/s00268-014-2510-6. — View Citation

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Hollinsky C, Sandberg S. Measurement of the tensile strength of the ventral abdominal wall in comparison with scar tissue. Clin Biomech (Bristol, Avon). 2007 Jan;22(1):88-92. Epub 2006 Aug 10. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 days
Primary	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)	1 year
Primary	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)	3 years
Secondary	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	30 days
Secondary	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.	5 days postoperative
Secondary	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	10 days