Preoptimisation in Ventral Hernia Surgery

NCT ID: NCT07316426

Last Updated: 2026-01-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2029-09-01

Brief Summary

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The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.

Detailed Description

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Conditions

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Hernia Hernia, Ventral Hernia Incisional Hernia, Umbilical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a prospective, single-blinded, multicentre, randomised, controlled superiority trial employing a parallel-group design with an allocation ratio of 1:1.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The surgeon responsible for the follow-up assessments at 3 and 12 months postoperatively will be blinded to the participant's allocation to either the intervention or the control group.

Study Groups

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Intervention

The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption.

Group Type EXPERIMENTAL

preoptimisation programme

Intervention Type PROCEDURE

The intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery.

control

The control group will receive basic guidance on physical activity and weight management during the preoperative consultation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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preoptimisation programme

The intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with a ventral hernia with a defect width of at least 4 cm.
* Symptom burden related to the hernia sufficient to justify surgical intervention.
* Age ≥ 18 years.

Exclusion Criteria

* Expected survival of less than three years.
* Inability to comprehend oral and written information or to provide informed consent.
* Acute complication of the hernia requiring emergency surgical intervention.
* General condition characterised by severe limitations in physical functional capacity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Norrbotten

UNKNOWN

Sponsor Role collaborator

Region Västerbotten

OTHER_GOV

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gällivare hospital

Gällivare, Norrbotten County, Sweden

Site Status RECRUITING

Sunderby Hospital

Luleå, Norrbotten County, Sweden

Site Status RECRUITING

Lycksele Hospital

Lycksele, Västerbotten County, Sweden

Site Status NOT_YET_RECRUITING

Skellefteå Hospital

Skellefteå, Västerbotten County, Sweden

Site Status NOT_YET_RECRUITING

Umeå University Hospital

Umeå, Västerbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Gunnar Nordqvist, M.D.

Role: CONTACT

+46768227094

Viktor Holmdahl, Phd

Role: CONTACT

Facility Contacts

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Gunnar Nordqvist, MD

Role: primary

004697019876

Gunnar Nordqvist, MD

Role: primary

+46768227094

Nordqvist

Role: backup

Viktor Holmdahl, MD, Phd

Role: primary

+46730724411

Holmdahl

Role: backup

Mikael Lindmark, MD, Phd

Role: primary

0046739649215

Viktor Holmdahl, MD, Phd

Role: primary

0046730724411

Other Identifiers

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PreOpt

Identifier Type: -

Identifier Source: org_study_id

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