sIPOM vs pIPOM in Incisional Hernia Patients

February 2, 2023 updated by: Claudio Gambardella, University of Campania "Luigi Vanvitelli"

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
pIPOM Group
Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM)
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.
sIPOM Group
Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
36 months
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.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group
Time Frame: 30 days
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.
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
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sIPOM vs pIPOM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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