Prevention of Postoperative Hernias in Emergency Surgery

NCT06815822 | Recruiting

• 1 other identifier: CMUJK 5/2025
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to understand the risk factors and incidence of postoperative hernias among patients undergoing emergency surgery. The main question it aims to answer is: What is the incidence of postoperative hernias in this group of patients? A brief telephone interview will be conducted with participants who will be included in this study one year after the surgery. If the presence of a postoperative hernia is suspected, the patient will be invited to a follow-up visit to the surgical clinic, where the diagnosis will be confirmed by imaging tests.

Conditions

Incarcerated Hernia; Appendicitis Acute; Cholecystitis, Acute; Ileus; Perforated Gastro-duodenal Ulcers; Perforated Bowel

Keywords

postoperative hernia; trocar site hernia; parastomal hernia; incisional hernia; outcomes; emergency surgery

Outcome Measures

Primary Outcomes (3)

• Incisional hernia

  Occurrence of postoperative abdominal hernia in the incision line.

  From the moment of inclusion until one year from the date of surgery.

• Port-site hernia

  Occurrence of port-site hernia after laparoscopy.

  From the moment of inclusion until one year from the date of surgery.

• Parastomal hernia

  Occurrence of a parastomal hernia after open/laparoscopic stoma formation

  From the moment of inclusion until one year from the date of surgery.

Secondary Outcomes (2)

• Burst abdomen

  From the moment of inclusion in the study until 30 days after surgery.

• Surgical site infection

  From the moment of inclusion in the study until 30 days after surgery or 90 days in the case of mesh use (if the primary procedure was repair of an incarcerated hernia or the mesh was placed to prevent postoperative hernia).

Study Arms (2)

Laparotomy

Patients undergoing surgery for acute appendicitis/acute cholecystitis/incarcerated hernia/gastrointestinal perforation or obstruction via laparotomy.

Laparoscopic/robotic

Patients undergoing surgery for acute appendicitis/acute cholecystitis/incarcerated hernia/gastrointestinal perforation or obstruction via laparoscopy or robotic surgery.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The analyzed population will include adult patients operated on for the most common surgical conditions. Since this will be a multicenter study, the data will include different populations. The analyzed population will be fairly uniform in terms of indications for surgery. The analyzed cases will be diverse in terms of comorbidities, age, and gender.

You may qualify if:

• Patient age \> 18 years.
• Emergency or urgent surgery.
• Specific surgical indications (acute appendicitis, acute cholecystitis, incarcerated hernia, gastrointestinal perforation, and obstruction).

You may not qualify if:

• Lack of patient consent.
• Open abdomen technique applied.

Sponsors & Collaborators

• Jan Kochanowski University: lead

Study Sites (1)

Department of General Surgery, St Alexander Hospital

Kielce, 25-316, Poland

RECRUITING

Related Publications (11)

• Kvist M, Jensen TK, Snitkjaer C, Burcharth J. The clinical consequences of burst abdomen after emergency midline laparotomy: a prospective, observational cohort study. Hernia. 2024 Oct;28(5):1861-1870. doi: 10.1007/s10029-024-03104-x. Epub 2024 Jul 20.

  PMID: 39031235 BACKGROUND

• Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.

  PMID: 36026550 BACKGROUND

• Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9.

  PMID: 29322212 BACKGROUND

• Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.

  PMID: 25690673 BACKGROUND

• Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.

  PMID: 26206646 BACKGROUND

• Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.

  PMID: 29134456 BACKGROUND

• de Beaux AC, East B. Thoughts on Trocar Site Hernia Prevention. A Narrative Review. J Abdom Wall Surg. 2022 Dec 21;1:11034. doi: 10.3389/jaws.2022.11034. eCollection 2022.

  PMID: 38314166 BACKGROUND

• Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015.

  PMID: 26389785 BACKGROUND

• Sanders DL, Pawlak MM, Simons MP, Aufenacker T, Balla A, Berger C, Berrevoet F, de Beaux AC, East B, Henriksen NA, Klugar M, Langaufova A, Miserez M, Morales-Conde S, Montgomery A, Pettersson PK, Reinpold W, Renard Y, Slezakova S, Whitehead-Clarke T, Stabilini C. Midline incisional hernia guidelines: the European Hernia Society. Br J Surg. 2023 Nov 9;110(12):1732-1768. doi: 10.1093/bjs/znad284. No abstract available.

  PMID: 37727928 BACKGROUND

• Frassini S, Cobianchi L, Fugazzola P, Biffl WL, Coccolini F, Damaskos D, Moore EE, Kluger Y, Ceresoli M, Coimbra R, Davies J, Kirkpatrick A, Di Carlo I, Hardcastle TC, Isik A, Chiarugi M, Gurusamy K, Maier RV, Segovia Lohse HA, Jeekel H, Boermeester MA, Abu-Zidan F, Inaba K, Weber DG, Augustin G, Bonavina L, Velmahos G, Sartelli M, Di Saverio S, Ten Broek RPG, Granieri S, Dal Mas F, Fare CN, Peverada J, Zanghi S, Vigano J, Tomasoni M, Dominioni T, Cicuttin E, Hecker A, Tebala GD, Galante JM, Wani I, Khokha V, Sugrue M, Scalea TM, Tan E, Malangoni MA, Pararas N, Podda M, De Simone B, Ivatury R, Cui Y, Kashuk J, Peitzman A, Kim F, Pikoulis E, Sganga G, Chiara O, Kelly MD, Marzi I, Picetti E, Agnoletti V, De'Angelis N, Campanelli G, de Moya M, Litvin A, Martinez-Perez A, Sall I, Rizoli S, Tomadze G, Sakakushev B, Stahel PF, Civil I, Shelat V, Costa D, Chichom-Mefire A, Latifi R, Chirica M, Amico F, Pardhan A, Seenarain V, Boyapati N, Hatz B, Ackermann T, Abeyasundara S, Fenton L, Plani F, Sarvepalli R, Rouhbakhshfar O, Caleo P, Ho-Ching Yau V, Clement K, Christou E, Castillo AMG, Gosal PKS, Balasubramaniam S, Hsu J, Banphawatanarak K, Pisano M, Adriana T, Michele A, Cioffi SPB, Spota A, Catena F, Ansaloni L. ECLAPTE: Effective Closure of LAParoTomy in Emergency-2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings. World J Emerg Surg. 2023 Jul 26;18(1):42. doi: 10.1186/s13017-023-00511-w.

  PMID: 37496068 BACKGROUND

• Molasy B, Zamkowski M, Mitura K, Smietanski M. Prevention of Postoperative Hernias in Emergency Surgery - PROPHECY Trial. J Abdom Wall Surg. 2025 Jul 9;4:14765. doi: 10.3389/jaws.2025.14765. eCollection 2025.

  PMID: 40703916 DERIVED

MeSH Terms

Conditions

Appendicitis; Cholecystitis, Acute; Ileus; Intestinal Perforation; Incisional Hernia

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Intestinal Obstruction; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Bartosz Molasy, MD, PhD

  Medical College of the Jan Kochanowski University, Kielce, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Molasy, MD, PhD

CONTACT

+48413417814; bartosz.molasy@ujk.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The study protocol and informed consent form will be available before the start of the project. The clinical study report will be available after the end of the project. The IPD will be available for 2 years from the date of the end of the study.
• Access Criteria: Access will be open to all interested.

Locations

PL (1)