An interventional study of incisional hernia repair in Ventral Incisional Hernia and Abdominal Wall Hernia, sponsored by Algemeen Ziekenhuis Maria Middelares. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Treatment
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
Browse Hernia, Abdominal studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
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- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.
Procedure: incisional hernia repair
Patients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.
Procedure: incisional hernia repair
Incisional hernia repair for the treatment of wide ventral incisional hernias.
Length of postoperative hospital stay
Length of postoperative hospital stay
Time frame: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days
Skin-to-skin operative time
Skin-to-skin operative time from first incision until last skin suture
Time frame: Per-operative (minutes)
Conversion rate
Conversion rate from the robotic-assisted approach to the open approach
Time frame: Per-operative
Surgical site related complications
Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions
Time frame: 30 days
Readmission rate
Readmission rate
Time frame: 30 Days and 3 months postoperative
Post-anesthetic discharge scoring system
Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.
Time frame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
Postoperative visual analogue scale pain score
Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.
Time frame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
EuraHS Quality of Life Scoring
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.
Time frame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Body Image Scale
Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
Time frame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Hernia recurrence
Hernia recurrence
Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months
Postoperative complications
Postoperative complications classified acoording to the Clavien-Dindo Classification
Time frame: 30 days
Reoperation rate
Reoperation rate
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Jan 2028, 30 months later.
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This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Algemeen Ziekenhuis Maria Middelares