Parastomal HerniaHyPERNCT07064694
HyPER - Hybrid Parastomal Endoscopic Repair
An observational study of Parastomal Hernia, run by Swissmed Hospital at 1 site in Poland.
Trial summary
Retrospective single-center study analyzing long-term outcomes of Hybrid Parastomal Endoscopic Repair (HyPER) in 200 patients with symptomatic parastomal hernias, including recurrence, complications, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Hybrid Parastomal Endoscopic Repair (HyPER)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2013to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Disseminated malignancy * Contraindications to laparoscopy * Severely limited life expectancy
Who may be able to join
- Age ≥ 18 years
- Symptomatic parastomal hernia requiring surgical intervention
- Eligibility for elective surgery
- Preoperative classification using the European Hernia Society (EHS) system
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients
Retrospective single-center study analyzing long-term outcomes of Hybrid Parastomal Endoscopic Repair (HyPER) in 200 patients with symptomatic parastomal hernias, including recurrence, complications, and quality of life.
Read the detailed description
This is a retrospective, single-center observational study evaluating surgical management of symptomatic parastomal hernias using a standardized Hybrid Parastomal Endoscopic Repair (HyPER) technique. The HyPER method integrates laparoscopic and open approaches to enable comprehensive dissection, mesh reinforcement, and anatomical correction, including stoma relocation and soft tissue reconstruction when indicated.
All patients were classified preoperatively according to the European Hernia Society (EHS) classification. The procedure included laparoscopic adhesiolysis, open excision of the hernia sac, and laparoscopic intraperitoneal mesh fixation. A synthetic mesh (typically DynaMesh-IPST®) was used in most cases. In selected patients, a cost-effective alternative mesh was applied using a technique referred to as the "Baldachin modification," with an omental flap interposed to prevent adhesions.
The study included adult patients with symptomatic parastomal hernias who underwent elective surgery at a tertiary referral center for abdominal wall reconstruction. Exclusion criteria involved disseminated malignancy, contraindications to laparoscopy, and severely limited life expectancy. Patients were followed up in a dedicated outpatient setting with regular clinical and imaging assessments.
The aim of this study was to evaluate feasibility, safety, and the potential for broad implementation of the HyPER technique in the surgical treatment of parastomal hernias.
- Conditions
- Parastomal Hernia
- Being tested
- Hybrid Parastomal Endoscopic Repair (HyPER)
- Keywords
- HyPER, parastomal hernia, abdominal wall surgery, Hernioplasty, Hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Parastomal Endoscopic Repair (HyPER)Procedure or surgery
Combined laparoscopic and open surgical approach involving adhesiolysis, hernia sac excision, intraperitoneal mesh fixation, and stoma revision or relocation as indicated. Standard mesh used was DynaMesh-IPST®; in selected cases, a cost-effective modification with macroporous polypropylene mesh and omental interposition was applied.
| Study group | Role | What they receive |
|---|---|---|
| HyPER Procedure | Combined laparoscopic and open surgical technique for parastomal hernia repair, including adhesiolysis, sac excision, mesh implantation, and stoma relocation if needed. Receives: Procedure: Hybrid Parastomal Endoscopic Repair (HyPER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of parastomal hernia
Proportion of patients with clinically or radiologically confirmed recurrence of parastomal hernia following the HyPER procedure, as assessed during routine follow-up.
Measured: Up to 10 years postoperatively (mean follow-up 61 months)
Secondary outcomes (2)
Postoperative complications
Incidence of postoperative complications such as wound infections, seromas, bowel injury, and stoma-related issues requiring medical or surgical management.
Measured: Within 30 days postoperatively
Patient-reported quality of life
Patient-reported outcomes assessed using the Visual Analog Scale for Quality of Life (VAS-QoL), a 10-point scale ranging from 0 (worst possible health state) to 10 (best possible health state). Higher scores indicate improved physical comfort and psychosocial well-being. Preoperative and postoperative scores were collected during follow-up visits and compared.
Measured: Baseline and last follow-up (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startJan 2013
- Primary completionAug 2024
- Study completionAug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parastomal 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064694
- Sponsor's protocol ID
- HyPER-200
- Acronym
- HyPER
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, and figures) will be made available upon reasonable request to qualified researchers whose proposed use of the data has been approved by the study team and the institutional ethics board. Data will be shared for the purpose of academic, non-commercial research only. Interested investigators should contact the corresponding author by email.
Publications
Szczepkowski M, Zamkowski M, Alicja S, Piotr W, Smietanski M. Evaluating EHS parastomal hernia classification for surgical planning: a retrospective analysis of 160 consecutive cases in a single center. Hernia. 2024 Oct;28(5):1915-1923. doi: 10.1007/s10029-024-03121-w. Epub 2024 Aug 10.
PubMed 39123085Szczepkowski M, Przywozka-Suwala A, Ziolkowski B, Witkowski P, Perea J. Hybrid parastomal hernia endoscopic repair (HyPER): novel approach to parastomal hernia surgery. Br J Surg. 2024 Apr 3;111(4):znae092. doi: 10.1093/bjs/znae092. No abstract available.
PubMed 38593041Szczepkowski M, Skoneczny P, Przywozka A, Czyzewski P, Bury K. New minimally invasive technique of parastomal hernia repair - methods and review. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):1-7. doi: 10.5114/wiitm.2015.50052. Epub 2015 Apr 14.
PubMed 25960785Smietanski M, Szczepkowski M, Alexandre JA, Berger D, Bury K, Conze J, Hansson B, Janes A, Miserez M, Mandala V, Montgomery A, Morales Conde S, Muysoms F. European Hernia Society classification of parastomal hernias. Hernia. 2014 Feb;18(1):1-6. doi: 10.1007/s10029-013-1162-z. Epub 2013 Oct 1.
PubMed 24081460Antoniou 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 29134456
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients
- ClinicalTrials.gov ID
- NCT07064694
- Acronym / sponsor ID
- HyPER / HyPER-200
- Conditions
- Parastomal Hernia
- Keywords
- HyPER, parastomal hernia, abdominal wall surgery, Hernioplasty, Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Swissmed HospitalUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2024 (actual)
- Study completion
- Aug 2024 (actual)
- First posted
- 15 Jul 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.
Retrospective single-center study analyzing long-term outcomes of Hybrid Parastomal Endoscopic Repair (HyPER) in 200 patients with symptomatic parastomal hernias, including recurrence, complications, and quality of life.
Detailed description
This is a retrospective, single-center observational study evaluating surgical management of symptomatic parastomal hernias using a standardized Hybrid Parastomal Endoscopic Repair (HyPER) technique. The HyPER method integrates laparoscopic and open approaches to enable comprehensive dissection, mesh reinforcement, and anatomical correction, including stoma relocation and soft tissue reconstruction when indicated.
All patients were classified preoperatively according to the European Hernia Society (EHS) classification. The procedure included laparoscopic adhesiolysis, open excision of the hernia sac, and laparoscopic intraperitoneal mesh fixation. A synthetic mesh (typically DynaMesh-IPST®) was used in most cases. In selected patients, a cost-effective alternative mesh was applied using a technique referred to as the "Baldachin modification," with an omental flap interposed to prevent adhesions.
The study included adult patients with symptomatic parastomal hernias who underwent elective surgery at a tertiary referral center for abdominal wall reconstruction. Exclusion criteria involved disseminated malignancy, contraindications to laparoscopy, and severely limited life expectancy. Patients were followed up in a dedicated outpatient setting with regular clinical and imaging assessments.
The aim of this study was to evaluate feasibility, safety, and the potential for broad implementation of the HyPER technique in the surgical treatment of parastomal hernias.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HyPER Procedure | – | Procedure: Hybrid Parastomal Endoscopic Repair (HyPER)Combined laparoscopic and open surgical technique for parastomal hernia repair, including adhesiolysis, sac excision, mesh implantation, and stoma relocation if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Disseminated malignancy * Contraindications to laparoscopy * Severely limited life expectancy
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Symptomatic parastomal hernia requiring surgical intervention
- Eligibility for elective surgery
- Preoperative classification using the European Hernia Society (EHS) system
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Parastomal Endoscopic Repair (HyPER)Combined laparoscopic and open surgical approach involving adhesiolysis, hernia sac excision, intraperitoneal mesh fixation, and stoma revision or relocation as indicated. Standard mesh used was DynaMesh-IPST®; in selected cases, a cost-effective modification with macroporous polypropylene mesh and omental interposition was applied. | Procedure or surgery | HyPER Procedure |
Primary outcome
Recurrence rate of parastomal hernia
Time frame: Up to 10 years postoperatively (mean follow-up 61 months)
Proportion of patients with clinically or radiologically confirmed recurrence of parastomal hernia following the HyPER procedure, as assessed during routine follow-up.
2 secondary outcomes
Postoperative complications
Time frame: Within 30 days postoperatively
Patient-reported quality of life
Time frame: Baseline and last follow-up (up to 10 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Results publication: PubMed 39123085Szczepkowski M, Zamkowski M, Alicja S, Piotr W, Smietanski M. Evaluating EHS parastomal hernia classification for surgical planning: a retrospective analysis of 160 consecutive cases in a single center. Hernia. 2024 Oct;28(5):1915-1923. doi: 10.1007/s10029-024-03121-w. Epub 2024 Aug 10.
- Results publication: PubMed 38593041Szczepkowski M, Przywozka-Suwala A, Ziolkowski B, Witkowski P, Perea J. Hybrid parastomal hernia endoscopic repair (HyPER): novel approach to parastomal hernia surgery. Br J Surg. 2024 Apr 3;111(4):znae092. doi: 10.1093/bjs/znae092. No abstract available.
- Results publication: PubMed 25960785Szczepkowski M, Skoneczny P, Przywozka A, Czyzewski P, Bury K. New minimally invasive technique of parastomal hernia repair - methods and review. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):1-7. doi: 10.5114/wiitm.2015.50052. Epub 2015 Apr 14.
- Results publication: PubMed 24081460Smietanski M, Szczepkowski M, Alexandre JA, Berger D, Bury K, Conze J, Hansson B, Janes A, Miserez M, Mandala V, Montgomery A, Morales Conde S, Muysoms F. European Hernia Society classification of parastomal hernias. Hernia. 2014 Feb;18(1):1-6. doi: 10.1007/s10029-013-1162-z. Epub 2013 Oct 1.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, and figures) will be made available upon reasonable request to qualified researchers whose proposed use of the data has been approved by the study team and the institutional ethics board. Data will be shared for the purpose of academic, non-commercial research only. Interested investigators should contact the corresponding author by email.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Parastomal Hernia, run by Swissmed Hospital 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of parastomal hernia (time frame: Up to 10 years postoperatively (mean follow-up 61 months)). 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 NCT07064694, which also lists 5 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 17 Jul 2025.