Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)

NCT04436887 | Completed

• 1 other identifier: 11062018
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh \[Parietex Progrip (Medtronic) \] in order to prevent Incisional Hernia following midline emergent laparotomy in clean and clean-contaminated wounds.

Conditions

Incisional Hernia; Wound Infection

Outcome Measures

Primary Outcomes (8)

• 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

  Patients are postoperatively examined at 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

  Patients are postoperatively examined at 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

  Patients are postoperatively examined at 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.

  Patients are postoperatively examined at 24 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.

  Patients are postoperatively examined at 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.

  Patients are postoperatively examined at 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.

  Patients are postoperatively examined at 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.

  Patients are postoperatively examined at 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

NO INTERVENTION

Primary closure of midline laparotomy

Mesh closure

EXPERIMENTAL

Sub-lay permanent mesh supported the closure

Procedure: positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia

Interventions

positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia PROCEDURE

Sub-lay mesh supported closure 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 arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies \>20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.

Mesh 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 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, contaminated and dirty wounds
• wound length\<10 cm.

Sponsors & Collaborators

• Francesco Pizza: lead

Related Publications (2)

• Pizza F, D'Antonio D, Lucido FS, Del Rio P, Dell'Isola C, Brusciano L, Tolone S, Docimo L, Gambardella C. Is absorbable mesh useful in preventing parastomal hernia after emergency surgery? The PARTHENOPE study. Hernia. 2022 Apr;26(2):507-516. doi: 10.1007/s10029-022-02579-w. Epub 2022 Feb 23.

  PMID: 35195798 DERIVED

• Pizza F, D'Antonio D, Ronchi A, Lucido FS, Brusciano L, Marvaso A, Dell'Isola C, Gambardella C. Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS). Br J Surg. 2021 Jun 22;108(6):638-643. doi: 10.1093/bjs/znab068.

  PMID: 33907800 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding Process Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to treatment allocation. Patients were blinded to the surgical procedure performed until the final assessment of the study endpoints. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the intervention. The data were collected and analyzed by physicians who were not involved in the patient's management during the whole Randomized Controlled Trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of bariatric unit

Model Details: Sample size: Considering a mean percentage of incidence of Incisional Hernia of 20% in the open middle line laparotomy in the clean-contemned setting. We hypothesized that Incisional Hernia rate in Group B (Experimental Group) would be superior to Group A (control group) if the difference in a mean percentage of incidence of Incisional Hernia was less than 15%. 194 patients are required to have a 90% chance of detecting, as significant at the 5% level, a decrease in the primary outcome measure from 20% in the control group to 5% in the experimental group. Baseline comparisons were performed using chi-square tests and T-tests. Continuous variables are expressed as mean ± standard deviation (SD). Differences between preoperative and postoperative parameters were compared by Wilcoxon paired rank test. For all tests, a two-sided p\<0.05 was considered statistically significant. The study designed with Sealed Envelope.

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 18, 2020
• Study Start: January 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share