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Completed

NCT Number: NCT06111287

Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

This multicenter retrospective study analyzed data from 308 patients who underwent open Posterior Component separation with Trasversus release for primary or recurrent complex abdominal hernias between 2015 and 2020. The primary endpoint was the rate of Hernia Recurrence and Mesh Bulging at 3, 6, 12, 24, and 36 months. Secondary outcomes included surgical site events and were assessed using the Pain scale.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Francdesco Pizza, Naples, Italy

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About this study

Study design This study is reported according to the STROBE statement for cohort studies A retrospective multicentric study was conducted to analyze the surgical outcomes of patients undergoing open with Posterior Component separation with Trasversus release for inisional hernia. It was conducted according to the ethical principles stated in the Declaration of Helsinki. Written informed consent was obtained from all subjects.

Study setting and study population From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open Posterior Component separation with Trasversus release referring to 6 centers, were considered for enrollment in the study. Inclusion criteria were age ≥16 years, primary or recurrent complex abdominal hernias with more than >10 cm midline defects Exclusion criteria were follow-up data lower than 36 months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥16 years,
  • primary or recurrent complex abdominal hernias with more than >10 cm midline defects

Exclusion criteria

  • follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Treatment and study plan

Primary outcomes

  1. Hernia Recurrence

    Time frame: 3 months

    In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  2. Hernia Recurrence

    Time frame: 6 months

    In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  3. Hernia Recurrence

    Time frame: 12 months

    In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  4. Hernia Recurrence

    Time frame: 24 months

    In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  5. Hernia Recurrence

    Time frame: 36 months

    In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  6. Mesh Bulging

    Time frame: 3 months

    In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  7. Mesh Bulging

    Time frame: 12 months

    In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  8. Mesh Bulging

    Time frame: 24 months

    In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  9. Mesh Bulging

    Time frame: 36 months

    In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.

  10. surgical site events

    Time frame: 1 months

    Regarding the surgical site events, the classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention wound classification (superficial, deep or organ space)

  11. Number of patients affected by Superficial surgical site infection

    Time frame: 1 months

    Superficial infections according to Clavien-Dindo criteria

Secondary outcomes

  1. Number of patients affected by Superficial surgical site infections

    Time frame: Within 30 days postoperatively

    Superficial infections according to Clavien-Dindo criteria

  2. Number of patients affected by Deep surgical site infections

    Time frame: Within 30 days postoperatively

    Deep surgical site infections according to Clavien-Dindo criteria

  3. Number of patients affected by organ space infections

    Time frame: Within 30 days postoperatively

    Organ space infections according to Clavien-Dindo criteria

  4. Number of patients affected by Surgical Site Occurence

    Time frame: Within 30 days postoperatively

    Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions

  5. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  6. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  7. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  8. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  9. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  10. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.

    Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Official study title

: Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study

Acronym: IMPACT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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