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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Number of participants with acute incisional hernia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The participant and investigator are masked
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Mesh reinforcement (Procedure)
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
Intervention: RTL reinforcement (Procedure)
Outcomes
Primary Outcomes
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: 3 years
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)
Secondary Outcomes
- Number of participants with seroma(10 days)
- Number of participants with surgical site infection(30 days)
- abdominal pain postoperative(5 days postoperative)
Investigators
Edgard Lozada
Master in clinical research
Hospital Regional de Alta Especialidad del Bajio