Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05596357 |
| Other study ID # |
2021-A01003-38 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2023 |
| Est. completion date |
March 1, 2030 |
Study information
| Verified date |
September 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
David MOSZKOWICZ, Pr |
| Phone |
0033147606384 |
| Email |
david.moszkowicz[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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
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).
