Clinical trial NCT04134455: The Mesh-RTL Project, for Prevention of Incisional Hernia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia Incisional
Keywords: Mesh
RTL(reinforced tension line)
Prevention
Prophylactic Mesh
Lead sponsor: Hospital Regional de Alta Especialidad del Bajio
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial of non-inferiority
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with acute incisional hernia
timeFrame: 30 days
measure: Number of participants with Incisional hernia
timeFrame: 1 year
measure: Number of participants with Incisional hernia
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with surgical site infection
timeFrame: 30 days
measure: abdominal pain postoperative
timeFrame: 5 days postoperative
measure: Number of participants with seroma
timeFrame: 10 days
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Hospital regional de Alta Especialidad del bajio
state: Guanajuato
Study officials:
affiliation: Hospital Regional de Alta Especialidad del Bajio
name: Jose de Jesus Alvarez Canales, Dr
role: STUDY_DIRECTOR
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