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HyPER - Hybrid Parastomal Endoscopic Repair

S

Swissmed Hospital

Status

Completed

Conditions

Parastomal Hernia

Treatments

Procedure: Hybrid Parastomal Endoscopic Repair (HyPER)

Study type

Observational

Funder types

Other

Identifiers

NCT07064694
HyPER-200

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

200 participants in 1 patient group

HyPER Procedure
Description:
Combined laparoscopic and open surgical technique for parastomal hernia repair, including adhesiolysis, sac excision, mesh implantation, and stoma relocation if needed.
Treatment:
Procedure: Hybrid Parastomal Endoscopic Repair (HyPER)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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