sIPOM vs pIPOM in Incisional Hernia Patients

CompletedOBSERVATIONAL
Enrollment

187

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Incisional Hernia
Interventions
PROCEDURE

Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)

The pneumoperitoneum (12-15 mmHg) was built up with Veres in the Palmer'point. The primary optical trocar was set in the left upper abdomen, two other trocars were set in the left middle and lower abdomen. If necessary, adhesiolysis was firstly performed. The hernia gap was deperitonealized in order to prevent a seroma formation and, if possible, all hernia sac was removed to facilitate the healing of the hernia defect after the laparoscopic suture. This also included the transection of the ligamentum teres hepatis. We reduced the intraabdominal pressure to approx. 5 mmHg and measured the hernia gap through an intraperitoneal graduated mark. The choice of mesh size was done with an overlap of more than 5 cm. The laparoscopic closure of the hernia defect was performed with non-reabsorbable detached stitches of prolene 1/0 suture at a distance of 1.5 cm from stich to stich using a Reverdin' needle. The final fixation of the mesh took place with a non-resorbable tacks.

PROCEDURE

Standard intraperitoneal onlay mesh repair (sIPOM)

The pneumoperitoneum (12-15 mmHg) was built up with Veres in the Palmer'point. The primary optical trocar was set in the left upper abdomen, two other trocars were set in the left middle and lower abdomen. If necessary, adhesiolysis was firstly performed. The hernia gap was deperitonealized in order to prevent a seroma formation and, if possible, all hernia sac was removed to facilitate the healing of the hernia defect after the laparoscopic suture. This also included the transection of the ligamentum teres hepatis. We reduced the intraabdominal pressure to approx. 5 mmHg and measured the hernia gap through an intraperitoneal graduated mark. The choice of mesh size was done with an overlap of more than 5 cm. In sIPOM, the defect was not closed. The final fixation of the mesh took place with a non-resorbable tacks.

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER

NCT05712213 - sIPOM vs pIPOM in Incisional Hernia Patients | Biotech Hunter | Biotech Hunter