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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Kymenlaakso Central Hospital Kotka Finland | OTHER |
| Päijät Häme Central Hospital | OTHER |
| Seinajoki Central Hospital |
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Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).
Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).
Patients are randomized to operative groups (lap. vs hybrid).
Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score (VAS) are reported.
The primary end-points:
The secondary end-points:
Hypothesis: Using a hybrid method seroma formation and hernia recurrence can be diminished.
Patient exclusion criteria:
Age< 18 y or > 80 y ASA >4 (the American Society of Anaesthesiologists' classification of Physical Health) BMI> 40 A previous mesh repair of the hernia Hernia defect size <2 or >7 cm Emergency operation
Eligible patients are randomized into two operative groups (lap/hybrid). In the laparoscopic group the hernia defect is covered with a Parietex composite mesh (using minimum of 5 cm marginals, Securestrap fixation instrument and four lifting strings. In hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. After this, a mesh repair is performed laparoscopically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic repair | Active Comparator | patients who are randomized to have a laparoscopic mesh repair |
|
| hybrid repair | Active Comparator | patients who are randomized to have a laparoscopic mesh repair and fascial closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic repair | Procedure | operative method |
| |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with seroma formation | 1 month | |
| number of patients with hernia recurrence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with peri/postoperative complications | complications are reported perioperatively, during hospital stay, in 1 month control and in 1 year control | up to 1 year |
| VAS pain scale |
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Inclusion Criteria:
-Patients with incisional hernia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tero Rautio, MD, PhD | Oulu University Hospital | Study Director |
| Mirella Ahonen-Siirtola, MD | Oulu University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30941550 | Derived | Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results. Surg Endosc. 2020 Jan;34(1):88-95. doi: 10.1007/s00464-019-06735-9. Epub 2019 Apr 2. | |
| 29882170 |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| D049291 | Seroma |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| OTHER |
| Kuopio University Hospital | OTHER |
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| Hybrid repair |
| Procedure |
operative method |
|
Pain scores (VAS) are measured during hospital day (average 3 days), in 1 month control and in 1 year control
| 1 year |
| Quality of Life | patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control | preoperative-1month-1year |
| Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results. Hernia. 2018 Dec;22(6):1015-1022. doi: 10.1007/s10029-018-1784-2. Epub 2018 Jun 7. |
| D007249 | Inflammation |