Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative pain management
Study Overview
Brief Summary
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).
Detailed Description
See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Group 1 (eTEP):
- •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
- •Group 1 (eTEP):
- •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
Outcomes
Primary Outcomes
Postoperative pain management
Time Frame: From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.
Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration
Length of hospital stay
Time Frame: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.
Time (days) spent within the hospital
Secondary Outcomes
- Intraoperative complications(During surgery)
- Postoperative complications(After discharge until 30 days postoperative)