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

NCT02136628 | Completed Phase 4 DMC

• 1 other identifier: CI-HRAEB_2013-020
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

RTL Technique

Outcome Measures

Primary Outcomes (1)

• Posincisional hernia prevention

  Participants surgeons evaluate the patient postoperatively until his discharge, and for 6 months in the outer query. the presence of incisional hernia will be determined in clinical fashion by the loss of continuity of the abdominal wall after surgical closure, with the formation of a peritoneal sac and the protrusion of different structures of the cavity, clinically by the presence of a bulge in the region of secondary wound a physical effort as well as palpation of a defect in the continuity of the wound in the abdominal wall. For diagnosis a CT scan in which the area of the disruption will be evaluated as well as the size and the organs involved, place the tomographic sign will define is the separation distance of the upright which must not exceed 25 mm.

  6 months

Study Arms (2)

RTL

EXPERIMENTAL

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.

Procedure: Method RTL

Control

NO INTERVENTION

Conventional midline mass closure technique. Upon completion of the surgical procedure was the closure of abdominal wall which will be made with the number 0 monofilament PDS, starting with knot at one end of the wound, continuous with continuous súrgete, moving each point to a centimeter away from the other. Each point will be a distance of one centimeter from the edge of the fascia. At the opposite end of the wound the same procedure was initiated and found the two suture lines at the midpoint of the wound will proceed to tying the two sutures with 4 square knots.

Interventions

Method RTL PROCEDURE

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.

RTL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years undergoing elective or urgent laparotomy regardless of the underlying diagnosis .
• Patients who score 6 or higher on the scale of Van Ramshorst .
• Patients signed informed consent to participate in the study

You may not qualify if:

• Patients managed with open abdomen in those abdominal wall closure is not possible .
• Patients who do not have full data in the record and therefore are not classifiable according to the scale of Van Ramshorst .
• Patients for comorbidities and / or clinical status can not sign consent to participate in the study.
• Patients with history of previous midline laparotomy .

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Related Publications (1)

• Lozada-Hernandez EE, Mayagoitia-Gonzalez JC, Smolinski-Kurek RL, Montiel-Hinojosa L, Hernandez-Villegas L, Morales-Vargas JM, Perez-Sanchez KD, Orozco-Mosqueda A, Cano-Rosas M. Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial. Hernia. 2022 Apr;26(2):447-456. doi: 10.1007/s10029-020-02338-9. Epub 2021 Jan 5.

  PMID: 33398464 DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. D.

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 13, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10