Endoscopic eTEP Versus Open Rives-Stoppa

AZ Alma

Status: Completed

Conditions: Rectus Diastasis; Hernia, Ventral

Treatments: Procedure: Open Rives-Stoppa; Procedure: Endoscopic eTEP

Study type: Observational

Funder types: Other

Identifiers

NCT05446675

EC/EH/220608-SK

Details and patient eligibility

About

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).

Full description

See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

eTEP

Description:

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.

Treatment:

Procedure: Endoscopic eTEP

Rives-Stoppa, control

Description:

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).

Treatment:

Procedure: Open Rives-Stoppa