The Mesh-RTL Project, for Prevention of Incisional Hernia

NCT04134455 | Completed DMC

• 2 other identifiers: CI/HRAEB/2018/08MeshVsRTL
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Hernia Incisional

Keywords

Mesh; RTL(reinforced tension line); Prevention; Prophylactic Mesh

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Number of participants with surgical site infection

  30 days

• abdominal pain postoperative

  5 days postoperative

• Number of participants with seroma

  10 days

Study Arms (2)

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.

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

Procedure: RTL reinforcement

Interventions

Mesh reinforcement PROCEDURE

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.

Also known as: Prophylactic Mesh reinforcement

Onlay Mesh Reinforcement group

RTL reinforcement PROCEDURE

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

Also known as: Technique RTL

RTL reinforcement group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead

Study Sites (1)

Hospital regional de Alta Especialidad del bajio

León, Guanajuato, 37660, Mexico

Location

Related Publications (25)

• 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

  BACKGROUND

• Pelissier E, Armstrong O, Ngo P. Anatomía quirúrgica y vías de acceso del abdomen. EMC Elsevier Masson, Paris. 2011; 40-040: 1-40.

  BACKGROUND

• 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.

  PMID: 18267162 BACKGROUND

• van'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.

  PMID: 15098775 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19259615 BACKGROUND

• Le 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.

  PMID: 23142402 BACKGROUND

• Webster 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.

  PMID: 12643854 BACKGROUND

• van 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.

  PMID: 19898894 BACKGROUND

• Gómez CJ, Pere RC. Validación de un modelo de evisceración. Cir Esp. 2013. http://dx.doi.org/10.1016/j.ciresp.2012.12.0088

  BACKGROUND

• 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.

  PMID: 25690673 BACKGROUND

• Cherla 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.

  PMID: 28554782 BACKGROUND

• Marwah 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.

  PMID: 15654663 BACKGROUND

• Niggebrugge 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.

  PMID: 10334254 BACKGROUND

• Abbott DE, Dumanian GA, Halverson AL. Management of laparotomy wound dehiscence. Am Surg. 2007 Dec;73(12):1224-7.

  PMID: 18186376 BACKGROUND

• 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

  BACKGROUND

• Hollinsky C, Sandberg S. Measurement of the tensile strength of the ventral abdominal wall in comparison with scar tissue. Clin Biomech (Bristol). 2007 Jan;22(1):88-92. doi: 10.1016/j.clinbiomech.2006.06.002. Epub 2006 Aug 10.

  PMID: 16904247 BACKGROUND

• Hollinsky C, Sandberg S, Kocijan R. Preliminary results with the reinforced tension line: a new technique for patients with ventral abdominal wall hernias. Am J Surg. 2007 Aug;194(2):234-9. doi: 10.1016/j.amjsurg.2006.09.045.

  PMID: 17618812 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23712289 BACKGROUND

• Lopez-Cano M, Pereira JA, Lozoya R, Feliu X, Villalobos R, Navarro S, Arbos MA, Armengol-Carrasco M. PREBIOUS trial: a multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: rationale and design. Contemp Clin Trials. 2014 Nov;39(2):335-41. doi: 10.1016/j.cct.2014.10.009. Epub 2014 Nov 1.

  PMID: 25445313 BACKGROUND

• 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.

  PMID: 24663481 BACKGROUND

• Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.

  PMID: 28641875 BACKGROUND

• 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.

  PMID: 26076354 BACKGROUND

• Lozada Hernandez EE, Flores Gonzalez E, Chavarria Chavira JL, Hernandez Herrera B, Rojas Benitez CG, Garcia Bravo LM, Sanchez Rosado RR, Reynoso Gonzalez R, Gutierrez Neri Perez M, Reynoso Barroso MF, Soria Rangel J. The MESH-RTL Project for prevention of abdominal wound dehiscence (AWD) in high-risk patients: noninferiority, randomized controlled trial. Surg Endosc. 2024 Dec;38(12):7634-7646. doi: 10.1007/s00464-024-11358-w. Epub 2024 Oct 25.

  PMID: 39453454 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Jose de Jesus Alvarez Canales, Dr

  Hospital Regional de Alta Especialidad del Bajio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and investigator are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in clinical research

Model Details: Clinical trial of non-inferiority

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 22, 2019
• Study Start: January 20, 2022
• Primary Completion: January 30, 2022
• Study Completion: February 4, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: previous sending of email requesting it

Locations

ME (1)