HyPER - Hybrid Parastomal Endoscopic Repair

NCT07064694 | Completed

• 1 other identifier: HyPER-200
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parastomal Hernia

Keywords

HyPER; parastomal hernia; abdominal wall surgery; Hernioplasty; Hernia

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 10 years postoperatively (mean follow-up 61 months)

Secondary Outcomes (2)

• Postoperative complications

  Within 30 days postoperatively

• Patient-reported quality of life

  Baseline and last follow-up (up to 10 years)

Study Arms (1)

HyPER Procedure

Combined laparoscopic and open surgical technique for parastomal hernia repair, including adhesiolysis, sac excision, mesh implantation, and stoma relocation if needed.

Procedure: Hybrid Parastomal Endoscopic Repair (HyPER)

Interventions

Hybrid Parastomal Endoscopic Repair (HyPER) PROCEDURE

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.

HyPER Procedure

Eligibility Criteria

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

Study Population

* Disseminated malignancy * Contraindications to laparoscopy * Severely limited life expectancy

You may qualify if:

• Age ≥ 18 years
• Symptomatic parastomal hernia requiring surgical intervention
• Eligibility for elective surgery
• Preoperative classification using the European Hernia Society (EHS) system

Sponsors & Collaborators

• Swissmed Hospital: lead
• Medical University of Gdansk: collaborator

Study Sites (1)

Bielański Hospital

Warsaw, 01-809, Poland

Location

Related Publications (5)

• 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.

  PMID: 39123085 BACKGROUND

• Szczepkowski 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.

  PMID: 38593041 BACKGROUND

• Szczepkowski 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.

  PMID: 25960785 BACKGROUND

• Smietanski 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.

  PMID: 24081460 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

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 15, 2025
• Study Start: January 1, 2013
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication; available for 5 years.
• Access Criteria: Access will be granted following review and approval of a research proposal and execution of a data use agreement.

Locations

PL (1)