A Phase 4 interventional study of Control and Experimental in Incisional Hernia, sponsored by Hospital de Mataró. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Hospital de Mataró · Phase 4, Interventional, and Prevention
Among 22 studies in Incisional Hernia with a site in Spain — 5 open to participants now, 9 under way, none of them phase 3. Incisional Hernia · Spain.
Among the 22 studies in Incisional Hernia with a site in Spain, this one is the 3rd largest by enrollment of the 15 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 4, and was the 3rd registered.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
Browse Incisional Hernia studies →5 of the 22 studies in Incisional Hernia with a site in Spain are open now. Recruiting first, the newest first:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Sites in Spain
Ages 18+
Fernandez Zamora · Sites in Spain
Ages 18+
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Sites in Spain
Ages 18+
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Sites in Spain
Ages 18+
Hospital Universitari Joan XXIII de Tarragona. · Sites in Spain
Ages 18–99 · Healthy volunteers
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 38 Incisional Hernia studies recruiting now, 27 (71%) set no upper age limit and 2 (5%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
This study's enrollment of 200 is above the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Median enrollment 140 across the 15 interventional studies, 200 across the 7 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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2 of 22 have an industry lead sponsor. The 10 most frequent:
Hospital de Mataró is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Hospital de Mataró has 2 studies filed under Incisional Hernia — fewer than ten, so there is no comparison to draw.
1 of the studies in Incisional Hernia with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04794582Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalPrevention of Incisional Hernia After Renal Transplantation | 2026-12 |
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Among the 22 studies in Incisional Hernia with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.
Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Simple closure
Procedure: Control
Simple closure + mesh
Device: Experimental
Fascial closure with simple polydioxanone suture 2/0 stitches
Onlay polypropylene mesh placement (MN mesh)
Umbilical trocar site hernia incidence
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
Time frame: 3 years
Seroma incidence
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
Time frame: 6 months
Hematoma incidence
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
Time frame: 6 months
Wound infection incidence
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
Time frame: 6 months
Pain presence
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
Time frame: 6 months, 1 and 3 years
Hospital discharge
When patients leave the hospital after the intervention, measured by hours
Time frame: 48 hours
Operative time
Intervention duration, measured by minutes
Time frame: 2 hours
Return to regular activity
When patient return to job or regular activities after surgery, measured by days
Time frame: 6 months
Patient satisfaction
How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
Time frame: 3 years
Surgeon satisfaction
How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
Time frame: 3 years
Ran from Jan 2018 to primary completion in Dec 2020, 35 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospital de Mataró