sIPOM vs pIPOM in Incisional Hernia Patients

NCT ID: NCT05712213

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 187 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2022-06-30

Brief Summary

Nowadays, two intraperitoneal mesh approaches are commonly used in Laparoscopic Ventral Hernia Repair (LVHR): the simple intraperitoneal onlay mesh repair (sIPOM) and the intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM). The pIPOM has been introduced to reduce adverse events in incisional hernia (IH) surgery (i.e., seroma formation, recurrences etc ) associated to laparoscopic hernia repair, and satisfactory outcomes has been reported in several studies. In details, sequelae such mesh bulging seems to be less associated to pIPOM than sIPOM, even if the latter topic is matter of intense debate. The pIPOM has been introduced in the guidelines for the laparoscopic treatment of ventral and incisional abdominal wall hernias published by the International Endohernia Society (IEHS) in 2014. Despite prospective studies on the quality of IPOM-Plus are available, the evidence level for the statements in these guidelines remains low. The aim of this prospective analysis is to compare the postoperative outcomes of patients treated for Incisional hernia (IH) with sIPOM and pIPOM after 36 months follow-up in terms of recurrence and wound events.

Conditions

Incisional Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pIPOM Group

Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM)

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

Intervention Type: PROCEDURE

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.

sIPOM Group

Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM)

Standard intraperitoneal onlay mesh repair (sIPOM)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Incisional Hernia whit length >3 and <12 in width or length (Medium size according to European Hernia Society classification incisional hernias
• Body mass index (BMI) < 35 kg/m2
• Elective surgery setting
• Clean wound field according to the Centre for Disease Control and Prevention (CDC) wound classification (Grade I)

Exclusion Criteria

• Incisional hernia <3 or >12 cm
• Abdominal aortic aneurysm disorders
• Pregnancy or lactation
• Psychiatric illness
• Multifocal hernia defect
• Life expectancy<2 years
• Inflammatory bowel disease
• emergency setting

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Claudio Gambardella

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Liang W, Liu C, Xu S, Ma S, Zong Y, Yan X. Sprint interval training for cardiovascular prevention: a time-efficient alternative or an overstated promise? An umbrella review. Eur J Appl Physiol. 2025 Sep 24. doi: 10.1007/s00421-025-05975-z. Online ahead of print.

Reference Type: DERIVED

PMID: 40991003 (View on PubMed)

Pizza F, D'Antonio D, Lucido FS, Brusciano L, Mongardini FM, Dell'Isola C, Brillantino A, Docimo L, Gambardella C. IPOM plus versus IPOM standard in incisional hernia repair: results of a prospective multicenter trial. Hernia. 2023 Jun;27(3):695-704. doi: 10.1007/s10029-023-02802-2. Epub 2023 May 7.

Reference Type: DERIVED

PMID: 37149818 (View on PubMed)

Other Identifiers

sIPOM vs pIPOM

Identifier Type: -

Identifier Source: org_study_id