RecruitingNot ApplicableNCT06364306

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial


Sponsor

University Hospital, Basel, Switzerland

Enrollment

140 participants

Start Date

Jul 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). The main questions it aims to answer are: length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. Participants will: Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patient age >18 years
  • Informed consent obtained
  • Transverse diameter of ventral hernia >4cm - 15cm
  • Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment

Exclusion Criteria10

  • precedent hernia treatment with mesh placement in the retromuscular space
  • precedent anterior or posterior component separation or transversus abdominis release (TAR)
  • active wound infection
  • current cancer diagnosis
  • presence of ileostomy, colostomy or ileal conduit
  • liver disease defined by the presence of ascites
  • end-stage renal disease requiring dialysis
  • need of an emergency surgery
  • pregnancy
  • Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.

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Interventions

PROCEDURERobotically-assisted ventral hernia repair (RVHR)

3 8mm robotic trocars are placed intraabdominally and the DaVinci Xi-robotic system is docked. Adhesiolysis from any adherent structures to the abdominal wall is performed. Incision of the lateral verge of the retromuscular space and retromuscular dissection. Superior and inferior cross-over to the contralateral retromuscular space and dissection of the hernia sac. Unilateral or bilateral transversus abdominis release (TAR) is performed, if necessary. Running suture with absorbable barbed suture of the posterior rectus sheath and peritoneum, as appropriate. Synthetic retromuscular mesh placement with a mesh-size as large as the prepared surface allows. Closure of the anterior rectus sheath with absorbable barbed running suture. Port extraction, skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.

PROCEDUREOpen ventral hernia repair (OVHR)

Median laparotomy with a minimal length of the previous scar (in case of incisional hernia) and adhesiolysis is performed, where necessary, to liberate the abdominal wall and the ventral hernia from adhesions. Bilateral dissection of the posterior rectus sheath under visualisation and sparing of the epigastric vessels and neurovascular bundles. Closure of the posterior rectus sheath with a slowly-absorbable running suture. Indication for a uni- or bilateral TAR identical to the intervention group. Retromuscular synthetic mesh placement with a mesh-size as far as the prepared surface allows. Mesh fixation optional with either absorbable sutures to the posterior sheath or with glubran glue. Closure of the anterior rectus sheath with a slowly-absorbable running suture. Skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.


Locations(3)

Klinikum Kempten

Kempten (Allgäu), Bavaria, Germany

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Spital Oberwallis, Visp

Visp, Valais, Switzerland

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NCT06364306


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