Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.

NCT04471311 | Unknown

• 1 other identifier: 1872020
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.

Conditions

Incisional Hernia After Midline Laparotomy

Keywords

Incisional Hernia; Midline laparotomy; Contaminated wound

Outcome Measures

Primary Outcomes (8)

• Rate of Incisional Hernia at Ultrasound examination

  Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.

  3 months

• Rate of Incisional Hernia at Ultrasound examination

  Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.

  6 months

• Rate of Incisional Hernia at Ultrasound examination

  Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.

  12 months

• Rate of Incisional Hernia at Ultrasound examination

  Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.

  24 months

• Rate of Incisional Hernia at Clinical examination

  Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar

  3 months

• Rate of Incisional Hernia at Clinical examination

  Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar

  6 months

• Rate of Incisional Hernia at Clinical examination

  Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar

  12 months

• Rate of Incisional Hernia at Clinical examination

  Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar

  24 months

Secondary Outcomes (2)

• Number of patients affected by Superficial surgical site infections

  Within 30 days postoperatively

• Number of patients affected by Deep surgical site infections

  Within 30 days postoperatively

Study Arms (2)

Primary closure of midline laparotomy

NO INTERVENTION

Primary closure of midline laparotomy

Sub-lay mesh supported closure

EXPERIMENTAL

Sub-lay permanent mesh supported the closure

Procedure: Sub-lay mesh supported closure; Device: BIO-A (GORE) mesh

Interventions

Sub-lay mesh supported closure PROCEDURE

A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies \>20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.

Sub-lay mesh supported closure

BIO-A (GORE) mesh DEVICE

3 cm BIO-A Mesh strip

Sub-lay mesh supported closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• Clean-contaminated, contaminated wounds • midline laparotomy \>10 cm
• Informed consent

You may not qualify if:

• age \< 18 years;
• life expectancy \< 24 months (as estimated by the operating surgeon), - • pregnancy
• immunosuppressant therapy within 2 weeks before surgery
• clean and dirty wounds
• wound length\<10 cm.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

francesco Pizza

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesco Pizza

  Azienda Sanitaria Locale Napoli 2 Nord

  STUDY DIRECTOR

Central Study Contacts

Francesco Pizza

CONTACT

3338275449; francesco_pizza@libero.it

Francesco Pizza

CONTACT

francesco_pizza@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Bariatric Unit

Model Details: THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)