Preoptimisation in Ventral Hernia Surgery

NCT07316426 | Recruiting DMC

• 1 other identifier: PreOpt
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hernia; Hernia, Ventral; Hernia Incisional; Hernia, Umbilical

Keywords

preoptimisation; prehabilitation

Outcome Measures

Primary Outcomes (1)

• Complications at three months postoperatively

  Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.

  3 months postoperatively

Secondary Outcomes (13)

• Complications at twelve months postoperatively

  12 months postoperatively

• Patient-reported pain

  Measured at inclusion, preoperatively, 3 and 12 months postoperatively.

• Quality of life with EQ-5D

  Measured at inclusion, preoperatively, 3 and 12 months postoperatively.

• Aesthetic outcome

  Measured at clinical follow-upat 3 and 12 months postoperatively.

• Recurrence rate

  Measured at clinical follow-up at 3 and 12 months postoperatively.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Procedure: preoptimisation programme

control

NO INTERVENTION

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

Interventions

preoptimisation programme 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Region Norrbotten: collaborator
• Region Västerbotten: collaborator

Study Sites (5)

Gällivare hospital

Gällivare, Norrbotten County, 98238, Sweden

RECRUITING

Sunderby Hospital

Luleå, Norrbotten County, 94542, Sweden

RECRUITING

Lycksele Hospital

Lycksele, Västerbotten County, 92137, Sweden

NOT YET RECRUITING

Skellefteå Hospital

Skellefteå, Västerbotten County, 93141, Sweden

NOT YET RECRUITING

Umeå University Hospital

Umeå, Västerbotten County, Sweden

RECRUITING

MeSH Terms

Conditions

Hernia; Hernia, Ventral; Incisional Hernia; Hernia, Umbilical

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Postoperative Complications; Pathologic Processes; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Gunnar Nordqvist, M.D.

CONTACT

+46768227094; gunnar.nordqvist@umu.se

Viktor Holmdahl, Phd

CONTACT

viktor.holmdahl@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 5, 2026
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)