ACute Treatment of Incisional Ventral Hernia

NCT05620121 | Unknown

• 1 other identifier: 2022/0006983/P/IFSC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, retrospective study aims to examine surgical outcomes in non-elective surgery for incisional hernia. The main questions it aims to answer are:

• 30-day morbidity
• short- and long-term surgical outcomes Data will be retrospectively collected from participating centers and compared. Researchers will compare surgical outcomes of the minimally invasive and laparotomic approaches to see if there are relevant differences in surgical outcomes.

Conditions

Incisional Hernia

Keywords

Incisional Hernias; Minimally invasive surgery; Mesh; Emergency; Abdominal wall defects

Outcome Measures

Primary Outcomes (1)

• 30-day morbidity

  (according to Clavien-Dindo classification) in patients who underwent abdominal wall repair for Incisional Hernia with/without prosthetic material in urgent/emergent settings, with the laparoscopic or the laparotomic approach.

  first 30 days after surgery

Secondary Outcomes (5)

• 30-day mortality

  first 30 days after surgery

• 30-day hospital readmission rate

  first 30 days after surgery

• Reoperation rate

  01 january 2018 - 31 December 2021

• Short-term IH recurrence

  01 january 2018 - 31 December 2021

• Long-term IH recurrence

  01 january 2018 - 31 December 2021

Study Arms (2)

Minimally invasive IH surgery

Minimally invasive approach to incisional hernias in non-electice settings

Procedure: Surgery for Incisional hernias

Laparotomic IH surgery

Laparotomic approach to incisional hernias in non-electice settings

Procedure: Surgery for Incisional hernias

Interventions

Surgery for Incisional hernias PROCEDURE

Laparoscopic and laparoscopic abdominal wall repair for Incisional Hernia with/without prosthetic material in urgent/emergent settings, with/without direct closure of the defect (IPOM and IPOM +).

Laparotomic IH surgery; Minimally invasive IH surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients admitted to the participating surgical departments who underwent urgent/emergent surgery for Incisional Hernia, in the period between 1st January 2018 and 31st December 2021.

You may qualify if:

• Patients of both sexes,
• ≥ 18 years old
• IH surgery in urgent/emergent settings
• open or minimally invasive surgical approach

You may not qualify if:

• Pregnant women
• ≥ 80 years old patients
• primitive abdominal wall hernias
• perineal or parastomal hernias

Sponsors & Collaborators

• Ospedale San Camillo: lead

Study Sites (1)

Lorenzo Crepaz

Trento, 38100, Italy

RECRUITING

Related Publications (6)

• Stoppa RE. The treatment of complicated groin and incisional hernias. World J Surg. 1989 Sep-Oct;13(5):545-54. doi: 10.1007/BF01658869.

  PMID: 2683400 BACKGROUND

• Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023.

  PMID: 2143588 BACKGROUND

• Hartog FPJD, Sneiders D, Darwish EF, Yurtkap Y, Menon AG, Muysoms FE, Kleinrensink GJ, Bouvy ND, Jeekel J, Lange JF. Favorable Outcomes After Retro-Rectus (Rives-Stoppa) Mesh Repair as Treatment for Noncomplex Ventral Abdominal Wall Hernia, a Systematic Review and Meta-analysis. Ann Surg. 2022 Jul 1;276(1):55-65. doi: 10.1097/SLA.0000000000005422. Epub 2022 Feb 18.

  PMID: 35185120 BACKGROUND

• Rosen MJ, Jin J, McGee MF, Williams C, Marks J, Ponsky JL. Laparoscopic component separation in the single-stage treatment of infected abdominal wall prosthetic removal. Hernia. 2007 Oct;11(5):435-40. doi: 10.1007/s10029-007-0255-y. Epub 2007 Jul 24.

  PMID: 17646896 BACKGROUND

• Cox TC, Pearl JP, Ritter EM. Rives-Stoppa incisional hernia repair combined with laparoscopic separation of abdominal wall components: a novel approach to complex abdominal wall closure. Hernia. 2010 Dec;14(6):561-7. doi: 10.1007/s10029-010-0704-x. Epub 2010 Jul 27.

  PMID: 20661611 BACKGROUND

• Poelman M, Apers J, van den Brand H, Cense H, Consten E, Deelder J, Dwars B, van Geloven N, de Lange E, Lange J, Simmermacher R, Simons M, Sonneveld E, Schreurs H, Bonjer J. The INCH-Trial: a multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional hernia repair. BMC Surg. 2013 Jun 7;13:18. doi: 10.1186/1471-2482-13-18.

  PMID: 24499061 BACKGROUND

Related Links

• Trattamento laparoscopico del laparocele ed ernie ventrali - Linee guida italiane, SICE

MeSH Terms

Conditions

Incisional Hernia; Emergencies

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Lorenzo Crepaz

  Ospedale San Camillo

  STUDY DIRECTOR

Central Study Contacts

Lorenzo Crepaz

CONTACT

3408848802; lorenzo.crepaz1@gmail.com

Alberto Sartori

CONTACT

3495264673; dott.sartori@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 17, 2022
• Study Start: September 15, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)