Clinical Research Directory

SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR

Incisional hernia is a common condition after abdominal surgery and is often associated with pain, impaired physical function, and reduced quality of life. It may also be complicated by incarceration and strangulation, with the potential for acute and life-threatening events. Surgical repair is the only curative treatment, and in many cases requires complex abdominal wall reconstruction, with substantial morbidity and a risk of recurrence. In recent years, minimally invasive laparoscopic and robot-assisted surgery has gained an increasingly important role in the treatment of ventral hernias. Retromuscular mesh placement combined with closure of the fascial defect has been developed to combine biomechanical principles from open Rives-Stoppa reconstruction with the potential benefits of minimally invasive techniques. A key knowledge gap is which suture material should be used for defect closure: non-absorbable sutures, which provide permanent mechanical stability but leave permanent foreign material, or slowly absorbable sutures, which degrade over time and may reduce suture-related complications. In clinical practice, the choice is often driven by local tradition and surgeon preference rather than robust evidence. Evidence from abdominal wall closure after elective laparotomy supports the use of slowly absorbable suture material; however, those results cannot be directly transferred to minimally invasive ventral hernia surgery where mesh reinforcement, biomechanics, and healing processes differ. Randomized multicenter trials specifically evaluating the impact of suture material in laparoscopic or robot-assisted retromuscular ventral/incisional hernia repair are lacking. Against this background, the present trial compares slowly absorbable versus non-absorbable sutures in minimally invasive retromuscular incisional hernia repair, focusing on an objective long-term endpoint. CT-verified recurrence at 2 years was chosen as the primary endpoint to provide a robust and clinically meaningful measure of treatment effect. The hierarchical hypothesis framework (primary test of superiority and secondary test of non-inferiority) allows a clinically useful interpretation even if no statistically significant advantage is demonstrated. Although incisional hernia is a subset of ventral hernias and shares pathophysiological and surgical principles with other ventral hernias, this trial is restricted to incisional hernia, where recurrence is more common and suture choice is expected to be more decisive. This restriction aims to achieve a more homogeneous study population and improve internal validity

The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery

Ventral hernia repair is among the most common operations performed in the United States each year, yet the great majority of patients receive no structured rehabilitation for the persistent pain, weakness, and functional loss that can follow surgery. This project will establish whether a tailored, mind-and-body physical therapy program can be feasibly and equitably delivered within a novel trial design embedded in routine surgical care, generating the operational evidence needed to design a definitive efficacy trial. The results will directly inform post-operative care pathways, clinical practice guidelines, and payer coverage decisions for a surgical population exceeding 600,000 patients annually.

Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair

This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy. In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, Integrated Mesh-Fascial Closure (IMFC) is used, a standardized execution of the technique of mesh incorporation into the fascial closure described by Jamal et al (Hernia, 2013). The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

Shear-Wave Elastography

Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR. Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure. Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension.

Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair

This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.