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The Mesh-RTL Project, for Prevention of Incisional Hernia (RTL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134455
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Edgard Lozada, Hospital Regional de Alta Especialidad del Bajio

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


Condition or disease Intervention/treatment Phase
Hernia Incisional Procedure: Mesh reinforcement Procedure: RTL reinforcement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial of non-inferiority
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 20, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Onlay Mesh Reinforcement group
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.
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.
Other Name: Prophylactic Mesh reinforcement

Experimental: RTL reinforcement group
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
Procedure: 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
Other Name: Technique RTL




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. Number of participants with surgical site infection [ Time Frame: 30 days ]
    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

  2. abdominal pain postoperative [ Time Frame: 5 days 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.

  3. Number of participants with seroma [ Time Frame: 10 days ]
    presence of accumulation of clear body fluids in a place where the tissue has been removed by surgery, not associated with infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134455


Contacts
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Contact: Edgard Lozada, Master +52 1 4772672000 ext 1700 edgardlozada@hotmail.com

Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Investigators
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Study Director: Jose de Jesus Alvarez Canales, Dr Hospital Regional de Alta Especialidad del Bajio
  Study Documents (Full-Text)

Documents provided by Edgard Lozada, Hospital Regional de Alta Especialidad del Bajio:
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.
Ramirez 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.
Gómez CJ, Pere RC. Validación de un modelo de evisceración. Cir Esp. 2013. http://dx.doi.org/10.1016/j.ciresp.2012.12.0088
Hollinsky C, Sandberg S. A biomechanical study of the reinforced tension line. A technique for abdominal wall closure and incisional hernias. European surgery. 2007. 39. 2. 122-127
Lozada-Hernandez EE, Mayagoitia-Gonzalez JC, Smolinski KR, AlvarezCanales JJ, Montiel Hinojosa L, Hernandez Villegas L. Comparacion de dos tecnicas de sutura para cierre aponeurotico en laparotomia media en pacientes con alto riesgo para evisceracion posquirurgica. Rev Hispanoamericana Hernia.2016; 4(4): 137-143

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Responsible Party: Edgard Lozada, Master in clinical research, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT04134455    
Other Study ID Numbers: CI/HRAEB/2018/08
MeshVsRTL ( Other Identifier: Hraeb )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Database available for analysis
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years
Access Criteria: previous sending of email requesting it

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edgard Lozada, Hospital Regional de Alta Especialidad del Bajio:
Mesh
RTL(reinforced tension line)
Prevention
Prophylactic Mesh
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes