Preoptimisation in Ventral Hernia Surgery (PreOpt)

Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia; Hernia, Ventral; Hernia, Umbilical; Hernia Incisional
• Intervention / Treatment: Procedure: preoptimisation programme

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gunnar Nordqvist, M.D.; Phone Number: +46768227094; Email: gunnar.nordqvist@umu.se
• Study Contact Backup: Name: Viktor Holmdahl, Phd; Email: viktor.holmdahl@umu.se

Study Locations

• Sweden
  • Norrbotten County
    • Gällivare, Norrbotten County, Sweden, 98238
      • Recruiting
      • Gällivare hospital
      • Contact: Gunnar Nordqvist, MD; Phone Number: 004697019876; Email: gunnar.nordqvist@norrbotten.se
    • Luleå, Norrbotten County, Sweden, 94542
      • Recruiting
      • Sunderby Hospital
      • Contact: Gunnar Nordqvist, MD; Phone Number: +46768227094; Email: gunnar.nordqvist@norrbotten.se
      • Contact: Nordqvist; Email: gunnar.nordqvist@norrbotten.se
  • Västerbotten County
    • Lycksele, Västerbotten County, Sweden, 92137
      • Not yet recruiting
      • Lycksele Hospital
      • Contact: Viktor Holmdahl, MD, Phd; Phone Number: +46730724411; Email: viktor.holmdahl@umu.se
      • Contact: Holmdahl; Email: viktor.holmdahl@umu.se
    • Skellefteå, Västerbotten County, Sweden, 93141
      • Not yet recruiting
      • Skellefteå Hospital
      • Contact: Mikael Lindmark, MD, Phd; Phone Number: 0046739649215; Email: mikael.lindmark@umu.se
    • Umeå, Västerbotten County, Sweden
      • Recruiting
      • Umea University Hospital
      • Contact: Viktor Holmdahl, MD, Phd; Phone Number: 0046730724411; Email: viktor.holmdahl@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: control; The control group will receive basic guidance on physical activity and weight management during the preoperative consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications at three months postoperatively	Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications at twelve months postoperatively	Incidence of surgical and medical complications at 12 months postoperatively.	12 months postoperatively
Patient-reported pain	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.	Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Quality of life with EQ-5D	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).	Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Aesthetic outcome	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.	Measured at clinical follow-upat 3 and 12 months postoperatively.
Recurrence rate	Recurrence of ventral hernia.	Measured at clinical follow-up at 3 and 12 months postoperatively.
Change in physical activity	changes in physical activity measured with accelerometer for one week.	meassured close to inclusion and within a few weeks preoperatively.
Weight	Weight measured i kg.	Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Collagen metabolism	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.	Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Hba1c	Hba1c in bloodsamples	at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.
Hernia aperature width	Hernia aperature width	measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion
B-PETH	B-PETH	at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.
Rutine labarotory tests	Number of participants with abnormal routine laboratory tests results	At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively
Hyaluronan metabolism	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.	Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Region Västerbotten; Region Norrbotten

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: prehabilitation; preoptimisation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia, Abdominal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Incisional Hernia; Hernia; Hernia, Ventral; Hernia, Umbilical
• Other Study ID Numbers: PreOpt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No