Incisional HerniaNCT05712213
sIPOM vs pIPOM in Incisional Hernia Patients
An observational study of Incisional Hernia, run by University of Campania Luigi Vanvitelli.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM) and Standard intraperitoneal onlay mesh repair (sIPOM)
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referring to the Departments of General Surgery of 3 Tertiary Hospitals (the "A. Rizzoli" Hospital, in Lacco Ameno Naples, the University of Campania "Luigi Vanvitelli" of Naples and the AORN "A. Cardareli" of Naples) for Incisional Hernia
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia
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
- Being tested
- Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM), Standard intraperitoneal onlay mesh repair (sIPOM)
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)Procedure or surgery
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.
Standard intraperitoneal onlay mesh repair (sIPOM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| pIPOM Group | Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM) Receives: Procedure: Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM) | |
| sIPOM Group | Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM) Receives: Procedure: Standard intraperitoneal onlay mesh repair (sIPOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Hernia Recurrence (HR) postoperatively in pIPOM Group and sIPOM Group
Hernia Recurrence (HR) in pIPOM and sIPOM, was clinically and ultrasonographically evaluated at outpatient visit. In details, HR was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. The ultrasonic criteria of HR were a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Size and location of all ultrasound detected HR were registered, as well as any other patient's complaint. In doubtful cases of HR, computerized tomography (CT) was performed. HR was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.
Measured: 36 months
Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group
Mesh Bulging (MB) as any clinically evident protrusion through the hernial defect and opens into the hernial sac causing swelling. It was as well clinically and ultrasonographically evaluated at outpatient visit. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. In doubtful cases of MB, computerized tomography (CT) was performed. MB was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.
Measured: 36 months
Secondary outcomes (2)
Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group
The classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention (CDC) wound classification (superficial, deep or organ space). Surgical site events were reported according to the Ventral Hernia Working Group definitions. Actions for wound events were categorized as follows: antibiotics only, bedside wound interventions, percutaneous maneuvers or surgical debridement.
Measured: 30 days
The evaluation of Quality of Life - Gastrointestinal quality of life index (GIQLI) questionnaire in pIPOM Group and sIPOM Group
The Gastrointestinal Quality of Life Index (GIQLI) is a validated, 36-item, self-administered questionnaire that addresses 5 domains: upper gastrointestinal symptoms (12 items), lower gastrointestinal symptoms (7 items), physical status (7 items), psychological status (5 items), and social status (5 items). Each item is quoted from 0 to 4; scores range from 0 to 144, with higher scores indicating better function. Correct or incorrect allocation was then evaluated.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2015
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Gambardella, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712213
- Sponsor's protocol ID
- sIPOM vs pIPOM
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Feb;126(2):1199-1220. doi: 10.1007/s00421-025-05975-z. Epub 2025 Sep 24.
PubMed 40991003Pizza 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.
PubMed 37149818
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia
- ClinicalTrials.gov ID
- NCT05712213
- Acronym / sponsor ID
- sIPOM vs pIPOM
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pIPOM Group | – | Procedure: Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM) |
| sIPOM Group | – | Procedure: Standard intraperitoneal onlay mesh repair (sIPOM)Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referring to the Departments of General Surgery of 3 Tertiary Hospitals (the "A. Rizzoli" Hospital, in Lacco Ameno Naples, the University of Campania "Luigi Vanvitelli" of Naples and the AORN "A. Cardareli" of Naples) for Incisional Hernia
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- Incisional hernia <3 or >12 cm
- Abdominal aortic aneurysm disorders
- Pregnancy or lactation
- Psychiatric illness
- Multifocal hernia defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | pIPOM Group |
| 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. | Procedure or surgery | sIPOM Group |
Primary outcome
Evaluation of the Hernia Recurrence (HR) postoperatively in pIPOM Group and sIPOM Group
Time frame: 36 months
Hernia Recurrence (HR) in pIPOM and sIPOM, was clinically and ultrasonographically evaluated at outpatient visit. In details, HR was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. The ultrasonic criteria of HR were a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Size and location of all ultrasound detected HR were registered, as well as any other patient's complaint. In doubtful cases of HR, computerized tomography (CT) was performed. HR was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.
Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group
Time frame: 36 months
Mesh Bulging (MB) as any clinically evident protrusion through the hernial defect and opens into the hernial sac causing swelling. It was as well clinically and ultrasonographically evaluated at outpatient visit. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. In doubtful cases of MB, computerized tomography (CT) was performed. MB was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.
2 secondary outcomes
Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group
Time frame: 30 days
The evaluation of Quality of Life - Gastrointestinal quality of life index (GIQLI) questionnaire in pIPOM Group and sIPOM Group
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 40991003Liang 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. 2026 Feb;126(2):1199-1220. doi: 10.1007/s00421-025-05975-z. Epub 2025 Sep 24.
- Derived from this study: PubMed 37149818Pizza 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.
Related trials for Incisional Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by University of Campania Luigi Vanvitelli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Hernia Recurrence (HR) postoperatively in pIPOM Group and sIPOM Group (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.