An observational study in Parastomal Hernia, sponsored by Swissmed Hospital. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Swissmed Hospital · Observational
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.
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.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 85 observational studies indexed under Hernia.
Browse Hernia studies →Swissmed Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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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)
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.
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.
Time frame: Up to 10 years postoperatively (mean follow-up 61 months)
Postoperative complications
Incidence of postoperative complications such as wound infections, seromas, bowel injury, and stoma-related issues requiring medical or surgical management.
Time frame: 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.
Time frame: Baseline and last follow-up (up to 10 years)
Plan to share: 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.
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.
Ran from Jan 2013 to primary completion in Aug 2024, 139 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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