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oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

ConditionsVentral HerniaIncisional HerniaAbdominal Wall Defect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotically-assisted ventral hernia repair (RVHR)

    Procedure/Surgery

    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.

  • Open ventral hernia repair (OVHR)

    Procedure/Surgery

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Robotically-assisted ventral hernia repair (RVHR)Experimental treatment 1 intervention
Group B: Open ventral hernia repair (OVHR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome: length of stay

Length of stay Length of stay is defined as the time from the operation until patient discharge is feasible according to the following criteria: * pain on numeric rating scale (NRS) \< 4 without opioid use * tolerance of oral food intake without nausea / vomiting * no signs of surgical site occurrence (SSO) or other postoperative complications * no drains in place * autonomy in daily living activities

Time frame
30 days

Secondary outcomes

1

Comprehensive complication index (CCI)

According to Slankamenac K, Graf R, Barkun J, Clavien P. The Comprehensive Complication Index. Ann Surg. 2013;258 The CCI ranges from 0 (no complications) to maximum 100 (death of the patient).

Time frame
30 days
2

Adverse events

* Intraoperative adverse events (bleeding, conversion rate, injury to bowel structures) * Postoperative adverse events (all other than surgical site occurrences such as ileus, pulmonary embolism, pneumonia, etc.) according to Clavien-Dindo Classification up to 30 days after surgery.

Time frame
30 days
3

pain after surgery

\- Pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a after 7days, 30 days, 6 months, 1, 3 and 5 years. The range fro the PROMIS ranges from 3 (no pain) to maximum of 15 (very severe pain) points.

Time frame
5 years
4

Functional recovery

Functional recovery measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire. The questionnaire uses 5 questions describing the patients health and abilities on that particular day and a visual analogue scale question (0 = worst, 100 = best) on the patients health on that particular day.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

St. Clara Hospital, Basel, Switzerland

Collaborator

Klinikum Kempten, Kempten, Germany

Collaborator

Hôpital du Valais

Collaborator

Source ClinicalTrials.gov
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