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NCT Number: NCT07064694

HyPER - Hybrid Parastomal Endoscopic Repair

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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Key information

Conditions

Parastomal Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bielański Hospital

Warsaw, 01-809, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. Recurrence rate of parastomal hernia

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

    Proportion of patients with clinically or radiologically confirmed recurrence of parastomal hernia following the HyPER procedure, as assessed during routine follow-up.

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 30 days postoperatively

    Incidence of postoperative complications such as wound infections, seromas, bowel injury, and stoma-related issues requiring medical or surgical management.

  2. Patient-reported quality of life

    Time frame: Baseline and last follow-up (up to 10 years)

    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.

Sponsors and collaborators

Lead sponsor

Swissmed Hospital

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study title

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

Acronym: HyPER

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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