Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

CompletedOBSERVATIONAL
Enrollment

31

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

December 31, 2022

Study Completion Date

January 1, 2025

Conditions
Parastomal Hernia
Interventions
DEVICE

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

"The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field.~Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh used:1. Parietex™ Composite Mesh (Medtronic, USA): A multifilament polyester mesh with an anti-adhesive collagen barrier to minimize visceral adhesions."

DEVICE

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

"The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field.~Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh use Synecor™ Hybrid Mesh (BD, USA): A macroporous mesh combining polypropylene with a bioresorbable layer that degrades over time, leaving a durable support structure to promote tissue integration."

Trial Locations (1)

80131

francesco Pizza, Naples

All Listed Sponsors
lead

Azienda Sanitaria Locale Napoli 2 Nord

OTHER

NCT06791642 - Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: | Biotech Hunter | Biotech Hunter