Clinical trial NCT06717061: Composed Abdominal Wall Analysis. Collecting Tissue and Blood From Patients Undergoing Elective Laparosopic Cholecystectomy. Objective to Describe the Normal Abdominal Wall
Official title: CAWA - Composed Abdominal Wall Analysis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hernia
Abdominal Wall
Keywords: hernia
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
First posted: 2024-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who will be eligible to be asked about participation in the research project are individuals who seek planned care for surgery on their gallbladder due to gallstone disease. The group of patients is chosen as they can represent a normal material that enables comparison with hernia-specific disease in the abdominal wall

Brief summary: People who will be eligible to be asked about participation in the research project are individuals who seek planned care for surgery on their gallbladder due to gallstone disease. The group of patients is chosen as they can represent a normal material that enables comparison with hernia-specific disease in the abdominal wall.

Basic data such as height, weight, sex, age, medication and ASA class will be collected in the form of a study form and stored in a database in a pseudonymised form. During the sampling of biological material, the test subjects will be under general anesthesia, which is why the sampling will not mean increased pain or discomfort other than what is standard after a gallbladder operation with the minimally invasive technique. No additional wound area will be added to the test subjects as the sample pieces are taken from the area at the umbilicus where one operates by default. The sampling is not planned to be repeated, but is performed at the time when the patients perform their cholecystectomy. During the sampling, centimeter-sized pieces of skin, fatty tissue, connective tissue and muscle are taken. Furthermore, serum and plasma will be collected. Two tubes of blood samples (10 ml total) are taken, centrifuged and pipetted before being frozen for later analysis. Pieces of tissue are placed in formalin before transport to the laboratory. The study form regarding the patient\&#39;s basic state of health will be filled in by the operator on the day of surgery and will be stored pseudonymized when the research subject is assigned a study number.

Patients who are troubled by gallstone disease and are referred for minimally invasive surgery of the gallbladder at the surgical center Västerbotten in Skellefteå will receive oral and written information and will be asked to participate in the study. Approximately 200 cholecystectomies are performed annually at Skellefteå hospital. We understand that within a reasonable period of time it will be possible to include 40 patients, which is the goal, also taking into account the exclusion criteria that exist. The inclusion of patients is expected to take approximately one year


Eligibility criteria: Inclusion Criteria:

- Individuals seeking planned care for surgery on their gallbladder due to gallstone disease

Exclusion Criteria:

* Disseminated cancer,
* Ongoing acute inflammation of the gallbladder,
* Known connective tissue disease,
* Cortisone medication,
* BMI \&amp;gt;35,
* Clinically measured rectus diastasis of \&amp;gt;4 cm and/or concurrent abdominal wall hernia
* Patients operated for abdominal wall hernia

Primary outcomes:
measure: Collagen composition differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
timeFrame: Five years from enrollment
Secondary outcomes:
measure: Collagen turnover differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
timeFrame: Five years from enrollment.
Other outcomes:
Locations:
city: Skellefteå
country: Sweden
facility: Kirurgcentrum Västerbotten
Study officials:
References: