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NCT06717061: CAWA

Composed Abdominal Wall Analysis. Collecting Tissue and Blood From Patients Undergoing Elective Laparosopic Cholecystectomy. Objective to Describe the Normal Abdominal Wall

ENROLLING BY INVITATION Last updated 4 December 2024
What this trial tests

trial testing Harvesting of biological material in Hernia in 40 participants. Enrolling by invitation.

Timeline
10 April 2024
Primary endpoint
10 December 2025
18 November 2026

Quick facts

Lead sponsorRegion Västerbotten
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment40
Start date10 April 2024
Primary completion10 December 2025
Estimated completion18 November 2026
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Region Västerbotten — full company profile →

Who can join

18 and older, any sex, with Hernia or Abdominal Wall. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Hernia

Currently open trials in the same condition.

Other Region Västerbotten trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06717061.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing