NCT07064694

HyPER - Hybrid Parastomal Endoscopic Repair

Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Swissmed Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2025-07-15
• Last updated: 2025-07-17

Locations

1 site across 1 country: Poland