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OpenTrials
Completed

NCT Number: NCT05712213

sIPOM vs pIPOM in Incisional Hernia Patients

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.

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Standard intraperitoneal onlay mesh repair (sIPOM)

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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