MedTrace Logo

Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method

NCT02136628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-10-26

No results posted yet for this study

Summary

The posincisional hernia is considered a delicate complication , with an incidence of 10-12% in patients undergoing laparotomy may reach 45% in case of emergency and high-risk patients . It is estimated that in the United States are made about a million of reoperations for correction of this complication , with millions and despite the myriad studies that have been done in recent years there has been a decrease in the incidence losses and mortality of this complication.

Given the seriousness of this problem the last global consensus guidelines sent to the surgical community in three main areas: Identify the importance of the problem, improve the theoretical knowledge and technical capacity in the closure of the abdominal wall and Implement prophylaxis in selected patients.

The technique of reinforced tension line (RTL) was proposed by hollinsky and collaborators and is a strengthening of the abdominal incision with placement of a suture that runs lateral to the edge of the incision and closure of the abdominal wall is performed the usual manner with the only surgete continuous suture for closure is placed lateral to the suture reinforcement.

In the present study may contribute to these guidelines and to groups of patients at high risk were identified and applying the RTL technique and demonstrate that its use is safe and useful in reducing the presence of this complication could be implemented as prophylaxis handling the same .

The RTL method was applied experimentally on bodies to close the abdominal wall also be used in a cohort of patients for hernia repair wall , showing that by using it the abdominal wall is more resistant to shear forces by theoretical foundation that exists to show that could prevent the development of incisional hernias. There are no studies in the literature comparing this technique against conventional methods of closure of the abdominal wall as to the prevention of the same.

Conditions

  • Hernia

Interventions

PROCEDURE

Method RTL

The method consists of two lines of suture, each, over the fascial wound edge. It starts with a suture strand (in this study was used PDS number 0) in one end of the fascial wound where the suture is run longitudinally and parallel to the aponeurotic edge. The needle should go in and out at intervals of 1 cm away and always kept at 0.5 cm from the edge of the fascia. Upon reaching the opposite angle of the wound suture strand another repeating the same process on the fascial edge otherwise used. The ends of the two suture strands are tied in fascial angles. Thus the fascial wound is sutured with two lines of strengthening its edges. Then proceed to close the wound with continuous súrgete always ensuring that the suture lines remain anchored on suture reinforcement.

Sponsors & Collaborators

  • Universidad de Guanajuato

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2015-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136628 on ClinicalTrials.gov