Clinical trial NCT04254237: Trocar Site Hernia After Laparoscopic Cholecystectomy, Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
Official title: Trocar Site Hernia After Laparoscopic Cholecystectomy: Randomized Clinical Trial Comparing Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Cholecystectomy, Laparoscopic
Keywords: Trocar site hernia
Laparoscopy
Laparoscopic cholecystectomy
Minimally invasive surgery
Lead sponsor: Complejo Hospitalario La Mancha Centro
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Ability to understand the trial information.
* Patients with symptomatic gallstones or polyps scheduled for laparoscopic cholecystectomy.
* Elective surgery.
* One year potential follow-up.
* Patients that experience one or more of the following Trocar Site Hernia risk factors:

  * Over 60 years old.
  * Obesity, defined as Body Mass Index (BMI) \> 30 Kg/m2.
  * Diabetes mellitus (DM).
  * Bronchopathy: A diagnosed Chronic Obstructive Pulmonary Disease (COPD) or smokers of more than 25 cigarette packages/year.
* Accept to participate in the study and sign the informed consent.

Exclusion Criteria:

* Contraindication to conduct a laparoscopic cholecystectomy.
* Patients with previous open supramesocolic surgery.
* Patients with previous surgery that affects the umbilical region.
* Patients with umbilical hernia or history of umbilical hernia surgical correction.
* A greater than 30 cm xifo-umbilical distance.
* Extreme obesity (Body Mass Index \> 50 kg/m2).
* Cancer patients or in immunosuppressive therapy.
* Connective tissue disease.

Primary outcomes:
measure: Trocar site hernia
timeFrame: One year
Secondary outcomes:
measure: Umbilical wound complications different from Trocar Site Hernia
timeFrame: 24 hours, 7 days, 30 days, 6 months and 1 year.
measure: Non-umbilical wounds complications
timeFrame: 24 hours, 7 days, 30 days, 6 months and 1 year.
measure: Other complications
timeFrame: 24 hours, 7 days, 30 days, 6 months and 1 year.
measure: Surgical time
timeFrame: Day 0
measure: Conversion
timeFrame: Day 0
measure: Hospital stay
timeFrame: Day 0
measure: Postoperative pain
timeFrame: 24 hours and 7 days after surgery.
measure: Perceived Quality of Life
timeFrame: baseline, one month and a year after surgery.
measure: Aesthetic result
timeFrame: Six months and a year of the surgery.
Other outcomes:
Locations:
city: Alcázar de San Juan
country: Spain
facility: La Mancha Centro General Hospital
state: Ciudad Real
city: Tomelloso
country: Spain
facility: Tomelloso General Hospital
state: Ciudad Real
city: Valdepeñas
country: Spain
facility: Valdepeñas General Hospital
state: Ciudad Real
Study officials:
affiliation: La Mancha Centro General Hospital
name: Antonio Morandeira-Rivas, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Mancha Centro General Hospital
name: Carlos Moreno Sanz, MD PhD FACS
role: STUDY_CHAIR
References: