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| Name | Class |
|---|---|
| Royal Belgian Society for Surgery | UNKNOWN |
| Archer Research | INDUSTRY |
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Patients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal width of 8 cm, treated according to the standard practice of the participating investigators.
Patients can be treated with the following ventral hernia repair approaches:
To evaluate the total number of days spent in the hospital within a period of 90 days post-operative. This will be calculated by adding the hospital length of stay for initial surgery or index-procedure, length of stay for any additional readmission resulting from the surgery or re-interventions, and emergency room visits resulting from the surgery or Serious Adverse Event (SAE) related to the index-procedure.
Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open and robotic ventral hernia repair.
Ventral hernia repair
Classifications and questionnaires
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic ventral hernia repair with closure of the defect | Other | In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general steps include safe entry into the peritoneum, insufflation and placement of the trocars to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is performed, which is the removal of scar tissue connecting tissues and organs. The content of the hernia, which may include intestine and fatty tissue, is returned into the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will be removed and the incisions are closed. |
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| Open ventral hernia repair with closure of the defect | Other | An open retromuscular ventral hernia repair involves an incision through the abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath is closed over the mesh, which closes the hernia. |
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| Robotic ventral hernia repair with closure of the defect | Other | A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar closure of the hernia defect and similar retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows the surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of the abdominal cavity. Rather than one long incision with open repair, four to six small incisions are made along the outer part of the abdomen between the rib cage and the hip. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality of life questionnaires | Other | pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of days in the hospital | This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery. The hospital length of stay for the initial surgery will be assessed using a Modified Post Anaesthetic Discharge Scoring System (PADSS) | 90 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative adverse events | Definitions according to ICH-GCP E6 (R2) | index procedure, 30 days post-operative, and 90 days post-operative |
| Number of participants with Surgical Site Infection (SSI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | East Flanders | 9000 | Belgium |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Investigator-initiated, academic, prospective, interventional, multicenter study
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CDC definition
| post-operative at 30 days, 1 year, and 2 years |
| Number of participants with Surgical Site Occurence (SSO) | Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam | post-operative at 30 days, 1 year, and 2 years |
| Operating time | Total operating time from incision to last stitch (in minutes) | index procedure |
| Effective day of discharge | Number of effective hospital stay after the index procedure | index procedure, and post-operative at 30 days |
| Conversion rate | Conversion rate for the laparoscopic and robot-assisted groups | index procedure |
| Preoperative and post-operative pain | Pain scoring using the Visual Analog Scale (VAS) The VAS scoring system is frequently used as a reliable and valid measure of pain. It contains a 0 - 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he / she experiences in rest and activity. The patient will be asked to bend over to score pain during activity. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0. | enrollment, post-operative at 30 days, 1 year, and 2 years |
| Analgesic intake | Amount and type of analgesic intake | post-operative at 30 days, 1 year, and 2 years |
| Quality of life improvement: Carolina's Comfort Scale (CCS) | Carolina's Comfort Scale (CCS) | enrollment, post-operative at 30 days, 1 year, and 2 years |
| Body image | Body Image Questionnaire (BIQ) The BIQ is a ten-item questionnaire incorporating body image and cosmetic subscales. The body image scale measures patients' perception and satisfaction with their bodies after surgery, and it is calculated by reverse scoring and summing the responses to questions 1 through 5. It ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars and is calculated by simply summing responses to questions 6 through 8, for a score range of 3 to 24, with a higher score indicating greater cosmetic satisfaction. The last two items (9, 10) score self-confidence before and after surgery. | enrollment, post-operative at 30 days, 1 year, and 2 years |
| Recurrence | Recurrent hernia | post-operative at 30 days, 1 year, and 2 years |