Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04254237 |
Other study ID # |
99-B |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 6, 2020 |
Est. completion date |
March 30, 2023 |
Study information
Verified date |
September 2023 |
Source |
Complejo Hospitalario La Mancha Centro |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Trocar site hernia is a specific complication of laparoscopic surgery. The increasingly
frequent use of the laparoscopic approach has resulted in an increase in the number of
hernias, mainly at the umbilical area. The appearance of a trocar site hernia can cause
complications in the short and long term to the patient who may end up needing a reoperation.
In this study we want to compare the supraumbilical versus the infraumbilical location of the
laparoscopy entry trocar, in terms of incisional hernia incidence.
Description:
Trocar site hernias have been considered as an underestimated problem by some surgeons. It's
incidence varies in the literature between studies, which may be related to an insufficient
diagnosis due to poor clinical manifestation and / or the lack of long-term follow-up of
patients in some studies.
There are many risk factors that have been related to the trocar site hernia development. On
one side, the patient clinical factors as the age, presence of obesity, diabetes mellitus or
the smoking habits. On the other side, some risk factors related to the surgical technique
have been described, as the entry technique, the size and the locations of the trocars, the
fascial closure, the duration of the surgery or the infection of the surgical wound.
Regarding the location of the trocars, it seems that the middle line has more risk of
incisional hernia than the lateral areas in the abdomen. However, the trocar locations out of
the middle line is not always possible, especially in certain surgeries as the laparoscopic
cholecystectomy where it can be necessary an expansion of the incision for removing the
specimen. In the concrete case of laparoscopic cholecystectomy, the belly is usually the most
popular region for placing the first trocar. However, there is not much evidence about the
influence of the most popular locations of the umbilical trocar incision (supra or
infraumbilical) in the development of incisional hernias.
In the middle line, the infraumbilical region presents a great ability to adapt to pressure
changes, as it physiologically occurs during the pregnancy. On the other side, while the
primary hernias in the supraumbilical and umbilical region are common, these are not produced
in the infraumbilical region. Besides, in anatomical studies of the linea alba, a higher
thickness of the fibres in the infraumbilical region has been observed, along with a
different spatial arrangement, predominating the transverse fibres in the infraumbilical
region and the oblique ones in the supraumbilical region. Therefore, we hypothesize whether
the infraumbilical location of the trocar in the midline, theoretically a more protected
region, can reduce the incidence of trocar site hernia in our patients.
The aim of this study is to compare the incidence of the Hasson trocar site hernia between
the supra and infraumbilical locations a year after surgery, in high risk patients for trocar
site hernia subjected to elective laparoscopic cholecystectomy.