HyPER - Hybrid Parastomal Endoscopic Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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

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Parastomal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HyPER Procedure

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

Hybrid Parastomal Endoscopic Repair (HyPER)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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