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Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).
See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eTEP | First 30 participants who meet the inclusion criteria and do not exhibit any of the exclusion criteria will be investigated. The option for endoscopic eTEP repair, if feasible, is given preoperatively as a standard for the treatment of symptomatic midline abdominal wall hernias with concomitant rectus abdominis diastasis as an alternative to open Rives-Stoppa mesh repair. The modality of operative treatment is made in cooperation with the participant. |
| |
| Rives-Stoppa, control | Thirty participants will be selected out of all patients who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center and who do not meet any of the exclusion criteria. Participant selection will consist of matching to participants in group 1 according to gender and age (e.g. a male participant in group 1 will be matched to a male participant (group 2) out of the investigators' records who underwent an open Rives-Stoppa repair and whose age most closely resembles the age of the matched participant in group 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic eTEP | Procedure | Endoscopic extended view totally extraperitoneal prosthesis repair. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Time (days) spent within the hospital | From the date of operation until the date of discharge from the hospital, assessed up to 30 days. |
| Postoperative pain management | Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration | From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | Adverse event occurrence | During surgery |
| Postoperative complications | Adverse event occurrence by readmission |
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Inclusion Criteria:
Group 1 (eTEP):
Group 2 (Rives-Stoppa, control group):
- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center
Exclusion Criteria:
Group 1 (eTEP):
Group 2 (Rives-Stoppa, control group):
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Participants who underwent repair for their midline abdominal wall hernias alongside rectus abdominis diastasis.
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| Name | Affiliation | Role |
|---|---|---|
| Sam Kinet, MD | AZ Alma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Alma | Eeklo | Oost-Vlaanderen | 9900 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38909352 | Derived | Kinet S, Maes H, Van Cleven S, Brusselaers N, Kuppens EFP. Endoscopic enhanced-view totally extraperitoneal prosthetic (eTEP) versus open Rives-Stoppa repair as a treatment of midline abdominal wall hernias with rectus diastasis: comparison of postoperative pain and length of hospital stay in a single-centre surgical cohort. Updates Surg. 2024 Dec;76(8):2923-2931. doi: 10.1007/s13304-024-01905-4. Epub 2024 Jun 23. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| EC/EH/220608-SK | Individual Participant Data Set | View IPD |
Study protocol will be sent to journal at time of application for publication after completion.
IPD will be shared via the online EHS registry with contents adhering to their format. Accessible to all EHS members for all types of analyses.
At completion of the study.
EHS-membership.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 26, 2022 | Feb 20, 2024 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Open Rives-Stoppa |
| Procedure |
Open Rives-Stoppa repair with retromuscular mesh placement. |
|
| After discharge until 30 days postoperative |