Incarcerated HerniaPROPHECYNCT06815822
Prevention of Postoperative Hernias in Emergency Surgery
An observational study of Incarcerated Hernia and Appendicitis Acute, run by Jan Kochanowski University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Incarcerated Hernia, Appendicitis Acute, Cholecystitis, Acute
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient age > 18 years.
- Emergency or urgent surgery.
- Specific surgical indications (acute appendicitis, acute cholecystitis, incarcerated hernia, gastrointestinal perforation, and obstruction).
Who cannot join
- Lack of patient consent.
- Open abdomen technique applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of General Surgery, St Alexander Hospital
Kielce, 25-316
Bartosz Molasy, MD, PhD, +48413417820, bartosz.molasy@ujk.edu.pl
About this study
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.
Read the detailed description
Introduction Emergency and urgent surgical procedures carry a high risk of complications. One of the long-term complications is postoperative hernia. Despite numerous studies analysing methods to reduce the incidence of this complication, it remains a significant surgical problem. Studies covering both elective and emergency procedures report that postoperative hernias occur in 2% to 40% of operated patients. The discrepancies in reported incidence rates may result from the asymptomatic nature of some hernias. An example is port-site hernias, for which the exact incidence is not fully determined. Another significant surgical issue is parastomal hernias, occurring in up to 50% of patients. Differences in the incidence of postoperative hernias also arise from the method and duration of patient follow-up. Due to these factors and the specificity of emergency procedures, the frequency of postoperative hernias is often underestimated in this patient group.
Considering the clinical consequences of postoperative hernias, preventing their occurrence is crucial. According to the literature, patients with diabetes, chronic lung disease, smoking habits, obesity, immunodeficiency, or a history of previous abdominal surgeries are at high risk of developing postoperative hernias. The European Hernia Society guidelines highlight the need for further research on methods for preventing postoperative hernias. The surgical approach and technique also influence the incidence of this complication. One of the technical factors is the method of fascial closure. According to the World Society of Emergency Surgery guidelines, the "small bites" technique is suggested for closing midline laparotomies to prevent postoperative hernias and wound complications in emergency surgery; however, the evidence comes from elective procedures. These guidelines emphasise the necessity of conducting prospective studies to confirm the efficacy of this technique in emergency and urgent surgeries. Other aspects of surgical technique, such as suture material, routine use of subcutaneous or intra-abdominal drains, and their impact on postoperative hernia incidence, remain a topic of debate.
The number of large, multicentre studies analysing prevention strategies for this complication is limited, especially concerning postoperative management. According to the available literature, including the European Hernia Society guidelines, the use of abdominal binders and the timing of full activity resumption remain controversial and require further investigation. Another known risk factor for postoperative hernias is surgical site infection, which affects approximately one-third of patients undergoing emergency procedures. A less common but significant surgical complication influencing postoperative hernia development is wound dehiscence, with an estimated incidence of around 4%. Both surgical site infections and wound dehiscence are associated with increased perioperative mortality, making the optimisation of therapeutic strategies to reduce their occurrence essential.
Objective The aim of this study is to determine the incidence of postoperative hernias among patients undergoing emergency surgery and to identify modifiable risk factors for their occurrence. Understanding these factors will help reduce the incidence of this complication and improve treatment outcomes by developing effective preventive strategies for this specific patient group.
Methodology This study will be a nationwide, prospective, cohort, multicentre observational study conducted from 1 June 2025 to 31 December 2026. It will be coordinated by the Department of Surgical Medicine with the Laboratory of Medical Genetics, Medical College, Jan Kochanowski University in Kielce. The study has been approved by the Bioethics Committee of Medical College, Jan Kochanowski University in Kielce (approval number: 5/2025).
The study plan is as follows:
- Recruitment of study centres - April/May 2025.
- Patient recruitment - 1 June 2025 - 31 December 2025.
- Follow-up period - 1 January 2026 - 31 December 2026.
- Data analysis - January 2027.
- Publication of study results - February/March 2027.
Inclusion and exclusion criteria:
Inclusion criteria:
- Patient age > 18 years.
- Emergency or urgent surgery.
- Specific surgical indications (acute appendicitis, acute cholecystitis, incarcerated hernia, gastrointestinal perforation, and obstruction).
Exclusion criteria:
- Lack of patient consent.
- Open abdomen technique applied.
The study will analyse data from medical history (comorbidities, previous surgical history) and selected preoperative laboratory tests. The method of fascial closure, use of intra-abdominal and subcutaneous drains, and postoperative management will also be assessed. Additionally, preventive measures for surgical site infections, such as wound irrigation, delayed wound closure, and negative pressure dressings, will be evaluated. The study will also examine preventive measures for postoperative hernias, including abdominal binders/tapes and the timing of full physical activity resumption.
Primary outcomes:
- Incidence of incisional hernia.
- Incidence of port-site hernia after laparoscopy.
- Incidence of parastomal hernia after open/laparoscopic stoma formation.
Secondary outcomes:
- Incidence of surgical site infection.
- Incidence of wound dehiscence.
Follow-up will be conducted via a brief telephone medical interview 12 months after hospital discharge to assess the incidence of postoperative hernias. If a postoperative hernia is suspected, the patient will undergo an outpatient examination, and the presence of a hernia will be confirmed via ultrasound or CT scan. After the follow-up period, each participating centre will submit an anonymised database to the study coordinator, where individual datasets will be consolidated for statistical analysis.
Statistical Analysis
The study will analyse the following data:
- Demographic: age, sex, BMI, comorbidities, ASA score, surgical indication.
- Operative: open vs. minimally invasive technique, type of surgery, fascial closure method, wound irrigation, use of subcutaneous drains, and prophylactic negative pressure dressings.
- Postoperative: prevention strategies for postoperative hernias, time to full physical activity resumption.
The incidence of primary outcomes will be assessed with a 95% confidence interval. The frequency of secondary outcomes (surgical site infection and wound dehiscence) will also be evaluated with a 95% confidence interval. Continuous variables will be presented as median with interquartile range, while categorical variables will be reported as case numbers and percentages. Student's t-test or Wilcoxon test will be used for comparing continuous variables, while the Chi-square test will be applied to categorical data. Univariate and multivariate logistic regression models will be developed to assess hernia risk factors. Relative risk for potential risk factors will also be calculated. A p-value < 0.05 will be considered statistically significant. Statistical analysis will be performed using R software in the RStudio environment.
To estimate the study sample size, a power analysis was conducted. A minimum of 255 cases is required to estimate the postoperative hernia incidence with 5% accuracy and a 95% confidence interval. For port-site hernias, at least 188 cases are needed, while for parastomal hernias, 349 cases are required. The required sample size for surgical site infections is 255 cases, and for wound dehiscence, 93 cases. The total study population will consist approximately 500 patients, which includes an estimated 10% dropout rate.
Authorship Criteria Investigators enrolling at least 40 patients will qualify for "named authorship" (two researchers per centre). Those enrolling 20-40 patients will qualify for "named authorship" (one researcher per centre). Researchers enrolling fewer than 20 patients will be listed under "collaborative authorship".
This study will contribute to the understanding of perioperative management in emergency surgery patients and improve treatment outcomes in this group.
- 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
- Medical subject headings
- Appendicitis, Cholecystitis, Acute, Ileus, Intestinal Perforation, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Occurrence of postoperative abdominal hernia in the incision line.
Measured: From the moment of inclusion until one year from the date of surgery.
Port-site hernia
Occurrence of port-site hernia after laparoscopy.
Measured: 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
Measured: From the moment of inclusion until one year from the date of surgery.
Secondary outcomes (2)
Burst abdomen
Occurrence of burst abdomen after surgery.
Measured: From the moment of inclusion in the study until 30 days after surgery.
Surgical site infection
Occurrence of surgical site infection.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Incarcerated HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Kochanowski University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Molasy, Jan Kochanowski University
- Investigators
- Bartosz Molasy, MD, PhD, Principal investigator, Medical College of the Jan Kochanowski University, Kielce, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815822
- Sponsor's protocol ID
- CMUJK 5/2025
- Acronym
- PROPHECY
- Status last verified
- May 2025
- First submitted
- 3 Feb 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared via the Medical College of the Jan Kochanowski University in Kielce website. The shared components will include the study protocol, informed consent form and clinical study report.
Publications
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.
PubMed 39031235Deerenberg 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.
PubMed 36026550Henriksen 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.
PubMed 29322212Goodenough 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.
PubMed 25690673Holihan 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.
PubMed 26206646Antoniou 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.
PubMed 29134456de 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.
PubMed 38314166Bosanquet 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.
PubMed 26389785Sanders 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.
PubMed 37727928Frassini 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.
PubMed 37496068Molasy 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.
PubMed 40703916
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Hernias in Emergency Surgery
- ClinicalTrials.gov ID
- NCT06815822
- Acronym / sponsor ID
- PROPHECY / CMUJK 5/2025
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jan Kochanowski UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction Emergency and urgent surgical procedures carry a high risk of complications. One of the long-term complications is postoperative hernia. Despite numerous studies analysing methods to reduce the incidence of this complication, it remains a significant surgical problem. Studies covering both elective and emergency procedures report that postoperative hernias occur in 2% to 40% of operated patients. The discrepancies in reported incidence rates may result from the asymptomatic nature of some hernias. An example is port-site hernias, for which the exact incidence is not fully determined. Another significant surgical issue is parastomal hernias, occurring in up to 50% of patients. Differences in the incidence of postoperative hernias also arise from the method and duration of patient follow-up. Due to these factors and the specificity of emergency procedures, the frequency of postoperative hernias is often underestimated in this patient group.
Considering the clinical consequences of postoperative hernias, preventing their occurrence is crucial. According to the literature, patients with diabetes, chronic lung disease, smoking habits, obesity, immunodeficiency, or a history of previous abdominal surgeries are at high risk of developing postoperative hernias. The European Hernia Society guidelines highlight the need for further research on methods for preventing postoperative hernias. The surgical approach and technique also influence the incidence of this complication. One of the technical factors is the method of fascial closure. According to the World Society of Emergency Surgery guidelines, the "small bites" technique is suggested for closing midline laparotomies to prevent postoperative hernias and wound complications in emergency surgery; however, the evidence comes from elective procedures. These guidelines emphasise the necessity of conducting prospective studies to confirm the efficacy of this technique in emergency and urgent surgeries. Other aspects of surgical technique, such as suture material, routine use of subcutaneous or intra-abdominal drains, and their impact on postoperative hernia incidence, remain a topic of debate.
The number of large, multicentre studies analysing prevention strategies for this complication is limited, especially concerning postoperative management. According to the available literature, including the European Hernia Society guidelines, the use of abdominal binders and the timing of full activity resumption remain controversial and require further investigation. Another known risk factor for postoperative hernias is surgical site infection, which affects approximately one-third of patients undergoing emergency procedures. A less common but significant surgical complication influencing postoperative hernia development is wound dehiscence, with an estimated incidence of around 4%. Both surgical site infections and wound dehiscence are associated with increased perioperative mortality, making the optimisation of therapeutic strategies to reduce their occurrence essential.
Objective The aim of this study is to determine the incidence of postoperative hernias among patients undergoing emergency surgery and to identify modifiable risk factors for their occurrence. Understanding these factors will help reduce the incidence of this complication and improve treatment outcomes by developing effective preventive strategies for this specific patient group.
Methodology This study will be a nationwide, prospective, cohort, multicentre observational study conducted from 1 June 2025 to 31 December 2026. It will be coordinated by the Department of Surgical Medicine with the Laboratory of Medical Genetics, Medical College, Jan Kochanowski University in Kielce. The study has been approved by the Bioethics Committee of Medical College, Jan Kochanowski University in Kielce (approval number: 5/2025).
The study plan is as follows:
- Recruitment of study centres - April/May 2025.
- Patient recruitment - 1 June 2025 - 31 December 2025.
- Follow-up period - 1 January 2026 - 31 December 2026.
- Data analysis - January 2027.
- Publication of study results - February/March 2027.
Inclusion and exclusion criteria:
Inclusion criteria:
- Patient age > 18 years.
- Emergency or urgent surgery.
- Specific surgical indications (acute appendicitis, acute cholecystitis, incarcerated hernia, gastrointestinal perforation, and obstruction).
Exclusion criteria:
- Lack of patient consent.
- Open abdomen technique applied.
The study will analyse data from medical history (comorbidities, previous surgical history) and selected preoperative laboratory tests. The method of fascial closure, use of intra-abdominal and subcutaneous drains, and postoperative management will also be assessed. Additionally, preventive measures for surgical site infections, such as wound irrigation, delayed wound closure, and negative pressure dressings, will be evaluated. The study will also examine preventive measures for postoperative hernias, including abdominal binders/tapes and the timing of full physical activity resumption.
Primary outcomes:
- Incidence of incisional hernia.
- Incidence of port-site hernia after laparoscopy.
- Incidence of parastomal hernia after open/laparoscopic stoma formation.
Secondary outcomes:
- Incidence of surgical site infection.
- Incidence of wound dehiscence.
Follow-up will be conducted via a brief telephone medical interview 12 months after hospital discharge to assess the incidence of postoperative hernias. If a postoperative hernia is suspected, the patient will undergo an outpatient examination, and the presence of a hernia will be confirmed via ultrasound or CT scan. After the follow-up period, each participating centre will submit an anonymised database to the study coordinator, where individual datasets will be consolidated for statistical analysis.
Statistical Analysis
The study will analyse the following data:
- Demographic: age, sex, BMI, comorbidities, ASA score, surgical indication.
- Operative: open vs. minimally invasive technique, type of surgery, fascial closure method, wound irrigation, use of subcutaneous drains, and prophylactic negative pressure dressings.
- Postoperative: prevention strategies for postoperative hernias, time to full physical activity resumption.
The incidence of primary outcomes will be assessed with a 95% confidence interval. The frequency of secondary outcomes (surgical site infection and wound dehiscence) will also be evaluated with a 95% confidence interval. Continuous variables will be presented as median with interquartile range, while categorical variables will be reported as case numbers and percentages. Student's t-test or Wilcoxon test will be used for comparing continuous variables, while the Chi-square test will be applied to categorical data. Univariate and multivariate logistic regression models will be developed to assess hernia risk factors. Relative risk for potential risk factors will also be calculated. A p-value < 0.05 will be considered statistically significant. Statistical analysis will be performed using R software in the RStudio environment.
To estimate the study sample size, a power analysis was conducted. A minimum of 255 cases is required to estimate the postoperative hernia incidence with 5% accuracy and a 95% confidence interval. For port-site hernias, at least 188 cases are needed, while for parastomal hernias, 349 cases are required. The required sample size for surgical site infections is 255 cases, and for wound dehiscence, 93 cases. The total study population will consist approximately 500 patients, which includes an estimated 10% dropout rate.
Authorship Criteria Investigators enrolling at least 40 patients will qualify for "named authorship" (two researchers per centre). Those enrolling 20-40 patients will qualify for "named authorship" (one researcher per centre). Researchers enrolling fewer than 20 patients will be listed under "collaborative authorship".
This study will contribute to the understanding of perioperative management in emergency surgery patients and improve treatment outcomes in this group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient age > 18 years.
- Emergency or urgent surgery.
- Specific surgical indications (acute appendicitis, acute cholecystitis, incarcerated hernia, gastrointestinal perforation, and obstruction).
Key exclusion criteria (2 listed)
- Lack of patient consent.
- Open abdomen technique applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incisional hernia
Time frame: From the moment of inclusion until one year from the date of surgery.
Occurrence of postoperative abdominal hernia in the incision line.
Port-site hernia
Time frame: From the moment of inclusion until one year from the date of surgery.
Occurrence of port-site hernia after laparoscopy.
Parastomal hernia
Time frame: From the moment of inclusion until one year from the date of surgery.
Occurrence of a parastomal hernia after open/laparoscopic stoma formation
2 secondary outcomes
Burst abdomen
Time frame: From the moment of inclusion in the study until 30 days after surgery.
Surgical site infection
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 39031235Kvist 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.
- Background: PubMed 36026550Deerenberg 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.
- Background: PubMed 29322212Henriksen 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.
- Background: PubMed 25690673Goodenough 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.
- Background: PubMed 26206646Holihan 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.
- Background: PubMed 29134456Antoniou 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.
- Background: PubMed 38314166de 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.
- Background: PubMed 26389785Bosanquet 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.
- Background: PubMed 37727928Sanders 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.
- Background: PubMed 37496068Frassini 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.
- Derived from this study: PubMed 40703916Molasy 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.
- Individual participant dataSharing planned: Yes. The IPD will be shared via the Medical College of the Jan Kochanowski University in Kielce website. The shared components will include the study protocol, informed consent form and clinical study report.
Related trials for Incarcerated Hernia
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Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bartosz Molasy, MD, PhD principal investigator
Medical College of the Jan Kochanowski University, Kielce, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incarcerated Hernia and Appendicitis Acute, run by Jan Kochanowski University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Molasy, MD, PhD (+48413417814, bartosz.molasy@ujk.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia (time frame: From the moment of inclusion until one year from the date of surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06815822, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.