An observational study in Hernia and Abdominal Wall, sponsored by Region Västerbotten. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Region Västerbotten · Observational
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\'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
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 85 observational studies indexed under Hernia.
Browse Hernia studies →Region Västerbotten is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are troubled by gallstone disease and are referred for laparoscopic 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. Once the blood samples have been taken, a research nurse will be on site in Skellefteå to collect the samples for centrifugation, pipetting and freezing. Serum and plasma will be shipped frozen to Umeå for analysis. Pieces of tissue are placed in formalin in the operating room and sent to the laboratory.
Procedure: Harvesting of biological material
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 peephole technique. . The sampling is not planned to be repeated, but is performed at the time when the patients perform their biliary surgery. 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\'s basic state of health will be filled in by the operator on the day of surgery.
Collagen composition differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
Are there detectable differences in collagen composition in the normal abdominal wall compared to patients who developed a primary or secondary abdominal wall hernia or abdominal rectus diastasis?
Time frame: Five years from enrollment
Collagen turnover differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
Are there detectable differences in hyaluronan levels, collagen metabolites, and other biological markers of collagen turnover in abdominal wall or blood when comparing patients with normal abdominal wall and subjects with diseased abdominal wall?
Time frame: Five years from enrollment.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.
Of 28 observational studies under Hernia, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 69. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Region Västerbotten