Clinical Trials Logo

Clinical Trial Summary

After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients


Clinical Trial Description

Almost 20% of patients operated on the abdomen will present with an incisional hernia and each year in France, more than 50,000 patients are operated on for an eventration with placement of a parietal mesh. These incisional hernia, corresponding to the permanent exteriorization of the abdominal viscera contained in a peritoneal sac through a scar muscle defect in the abdominal wall, are responsible for major anatomical and physiological alterations affecting the respiratory, cardiovascular and musculoskeletal systems. Sometimes the hernia sac is so large that the viscera have lost their place in the abdomen . The presence of a large protrusion of the anterior abdomen alters the patient's center of gravity, affecting his ambulation and posture Thus, surgical repair of the abdomen, indicated to correct chronic pain, functional limitation and cosmetic damage related to incisional hernia, helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of the patients. The consequent benefits on the quality of life and the reduction of chronic pain have been demonstrated by several studies, including a randomized trial [Rogmark, but certain aspects of the functional limitations linked to the presence of an eventration have never been studied (not published), as well as their specific impact on quality of life. In fact, the daily experience of the management of these pathologies suggests that most patients with an abdominal wall problem, on the one hand, evoke difficulties to exonerate (abdominal pushing efforts are rendered ineffective due to the leakage of abdominal pressure in the incisional hernia sac, sometimes forcing patients to contain their stomachs by manual maneuvers or to wear an abdominal belt) and on the other hand difficulty having sexual intercourse (gene linked to the protrusion of abdomen, impaired body image and self-esteem). Thus, a better knowledge of the actual digestive and sexual functional damage linked to these parietal pathologies, will make it possible to optimize the care of patients who will be better informed about their disease and the benefits they can expect from parietal repair (ease of having a bowel movement, improvement of sex life, benefits on quality of life). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05596357
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact David MOSZKOWICZ, Pr
Phone 0033147606384
Email david.moszkowicz@aphp.fr
Status Recruiting
Phase
Start date July 10, 2023
Completion date March 1, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT06016426 - Mass Closure vs Layer by Layer Closure N/A
Recruiting NCT05734222 - Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias N/A
Enrolling by invitation NCT03105895 - Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI N/A
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT02089958 - Standardization of Laparoscopic Hernia Repair N/A
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00498810 - COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL) N/A
Completed NCT04961346 - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair N/A
Terminated NCT03912662 - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention N/A
Recruiting NCT05620121 - ACute Treatment of Incisional Ventral Hernia
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Not yet recruiting NCT02896686 - Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure Phase 4
Recruiting NCT02277262 - PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM) Phase 4
Active, not recruiting NCT02328352 - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" Phase 1/Phase 2
Suspended NCT01520168 - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management N/A
Completed NCT05579652 - Change in Fascial Tension in Open Abdomens
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT02321059 - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia N/A