CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
Mesh reinforcement +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04134455
NCT04134455N/ACompleted

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

Hospital Regional de Alta Especialidad del Bajio·interventional·Posted Oct 22, 2019·Updated Feb 28, 2022

In Brief

A clinical study evaluating Mesh reinforcement and RTL reinforcement for Hernia Incisional. Completed, enrolled 250 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 22, 2019
Enrollment StartJan 20, 2022
Primary CompletionJan 30, 2022
Study CompletionFeb 4, 2022
TodayJul 2, 2026
Enrollment to primary: 10 daysPosted 6.7 years ago

Interventions

Mesh reinforcementprocedure

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 reinforcementprocedure

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