Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-06-09
2022-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
Endoscopic eTEP
Endoscopic extended view totally extraperitoneal prosthesis repair.
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).
Open Rives-Stoppa
Open Rives-Stoppa repair with retromuscular mesh placement.
Interventions
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Endoscopic eTEP
Endoscopic extended view totally extraperitoneal prosthesis repair.
Open Rives-Stoppa
Open Rives-Stoppa repair with retromuscular mesh placement.
Eligibility Criteria
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Inclusion Criteria
* Participants who underwent an eTEP procedure in the investigators' center
* Preoperative existence of one or more midline abdominal wall hernias
* Preoperative existence of rectus abdominis diastasis
Group 2 (Rives-Stoppa, control group):
\- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center
Exclusion Criteria
* Preoperative absence of midline abdominal wall hernias
* Preoperative absence of rectus abdominis diastasis
* Intraoperative performance of transverse abdominis release (TAR)
* Intraoperative inguinal hernia repair
Group 2 (Rives-Stoppa, control group):
* Intraoperative performance of transverse abdominis release (TAR)
* Intraoperative performance of anterior component separation
* Intraoperative inguinal hernia repair
ALL
No
Sponsors
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AZ Alma
OTHER
Responsible Party
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Principal Investigators
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Sam Kinet, MD
Role: PRINCIPAL_INVESTIGATOR
AZ Alma
Locations
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AZ Alma
Eeklo, Oost-Vlaanderen, Belgium
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Study Documents
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Document Type: Individual Participant Data Set
View DocumentOther Identifiers
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EC/EH/220608-SK
Identifier Type: -
Identifier Source: org_study_id
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