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NCT Number: NCT07316426

Preoptimisation in Ventral Hernia Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gällivare hospital, Gällivare, Norrbotten County, Sweden

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Complications at three months postoperatively

    Time frame: 3 months postoperatively

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

Secondary outcomes

  1. Complications at twelve months postoperatively

    Time frame: 12 months postoperatively

    Incidence of surgical and medical complications at 12 months postoperatively.

  2. Patient-reported pain

    Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.

    Patient-reported pain measured with Ventral Hernia Pain Questionnaire, VHPQ. Max score is 40 and minimum score is 0, a lower score indicates less abdominal wall pain.

  3. Quality of life with EQ-5D

    Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.

    Quality of life assessed using the EuroQol 5-Dimensions questionnaire (EQ-5D index score). Max score is 1.0, which equals to perfect health and a lower score indicates lower quality of life with 0 is equivalent to death. Negative scores indicated health states considered worse than dead (e.g. severe disability).

  4. Aesthetic outcome

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

    Patient reported aestethic outcome measured with a Numerical Ratin Scale, NRS scale, range 1-10 where a higher score indicates better patient reported aesthetic outcome.

  5. Recurrence rate

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

    Recurrence of ventral hernia.

  6. Change in physical activity

    Time frame: meassured close to inclusion and within a few weeks preoperatively.

    changes in physical activity measured with accelerometer for one week.

  7. Weight

    Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.

    Weight measured i kg.

  8. Collagen metabolism

    Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.

    Difference between study groups in the expression levels of a panel of markers of collagen degradation and synthesis (including CHP, Collagen 1 and 4, MMP) in tissue samples taken from fascia, muscle and skin.

  9. Hba1c

    Time frame: at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.

    Hba1c in bloodsamples

  10. Hernia aperature width

    Time frame: measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion

    Hernia aperature width

  11. B-PETH

    Time frame: at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.

    B-PETH

  12. Rutine labarotory tests

    Time frame: At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively

    Number of participants with abnormal routine laboratory tests results

  13. Hyaluronan metabolism

    Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.

    Difference between study groups in the expression patterns and histological distribution of hyaluronan and hyaluronan metabolism-related factors (including CD44, TRAMM, and hyaluronidases) in tissue samples taken from fascia, muscle and skin.

Study contacts

Contact information is provided by the study sponsor or research team.

Gunnar Nordqvist, M.D.

CONTACT

[email protected]

+46768227094

Viktor Holmdahl, Phd

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Norrbotten
  • Region Västerbotten

Registry information

Official study title

Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

Acronym: PreOpt

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

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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