Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial - Scorecard - MDSpire

Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial

  • By

  • Ana Ciscar

  • Emma Sánchez-Sáez

  • Marina Vila Tura

  • Patricia Ruiz de Leon

  • Marta Gomez Pallarès

  • Daniel Troyano Escribano

  • Marta Abadal Prades

  • Esther Mans Muntwyler

  • José-Antonio Pereira

  • Josep M. Badia

  • August 29, 2024

  • 0 min

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Clinical Scorecard: Evaluation of Polypropylene Onlay Mesh Effectiveness in Preventing Trocar-Site Incisional Hernias in High-Risk Surgical Patients: A Randomized Clinical Study

At a Glance

CategoryDetail
ConditionTrocar Site Incisional Hernia (TSIH) after laparoscopic surgery
Key MechanismsDefect in abdominal wall at trocar site post-laparoscopic surgery; prevention via prophylactic onlay polypropylene mesh placement
Target PopulationPatients undergoing laparoscopic cholecystectomy with ≥1 risk factor for TSIH (age ≥70, BMI ≥30 kg/m2, diabetes mellitus, or enlarged trocar incision)
Care SettingGeneral surgery units performing laparoscopic cholecystectomy

Key Highlights

  • TSIH incidence is underreported due to retrospective studies, insufficient follow-up, and heterogeneous diagnostics; recent reliable incidence ~25%.
  • Prophylactic onlay polypropylene mesh placement at umbilical trocar site hypothesized to reduce TSIH rate below 23% without increasing surgical site complications.
  • Randomized, double-blinded clinical trial conducted with 1:1 allocation comparing mesh vs. standard closure in high-risk patients.

Guideline-Based Recommendations

Diagnosis

  • Physical examination for TSIH diagnosis has limited accuracy.
  • Imaging studies such as abdominal CT or dynamic abdominal sonography for hernia (DASH) improve diagnostic accuracy.
  • Ultrasound at 12 months post-op used as reference standard for TSIH diagnosis.

Management

  • Standard laparoscopic cholecystectomy with primary fascial closure using absorbable monofilament sutures.
  • In high-risk patients, prophylactic placement of macropore, low molecular weight polypropylene mesh in onlay position over closed fascia at umbilical trocar site.
  • Mesh fixed with interrupted absorbable sutures arranged in a crown pattern.

Monitoring & Follow-up

  • Postoperative follow-up with physical examination at 1, 6, and 12 months by general surgeon.
  • Abdominal ultrasound at 12 months by specialist radiologist to detect TSIH.

Risks

  • Potential surgical site complications include seroma, hematoma, and infection; monitored as secondary outcomes.
  • No increase in surgical site complications expected with mesh placement based on study hypothesis.

Patient & Prescribing Data

Adults ≥18 years undergoing laparoscopic cholecystectomy with risk factors for TSIH

Prophylactic onlay polypropylene mesh may reduce TSIH incidence below 23% without increasing surgical site complications; requires standardized surgical technique and follow-up.

Clinical Best Practices

  • Identify patients at high risk for TSIH preoperatively (age ≥70, BMI ≥30, diabetes, enlarged trocar incision).
  • Use Hasson's open technique for pneumoperitoneum and standardized trocar placement.
  • Perform primary fascial closure with interrupted absorbable monofilament sutures spaced ~4 mm apart.
  • In intervention group, place macropore polypropylene mesh onlay over closed fascia with secure interrupted sutures.
  • Conduct systematic postoperative follow-up including clinical exams and imaging to detect TSIH.
  • Maintain double-blinded assessment to reduce bias in outcome evaluation.

References

Original Source(s)

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