HerniaCAWANCT06717061
Composed Abdominal Wall Analysis. Collecting Tissue and Blood From Patients Undergoing Elective Laparosopic Cholecystectomy. Objective to Describe the Normal Abdominal Wall
An observational study of Hernia and Abdominal Wall, run by Region Västerbotten at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Abdominal Wall
- What is being tested?
- Harvesting of biological material
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 10 Apr 2024to 18 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Individuals seeking planned care for surgery on their gallbladder due to gallstone disease
Who cannot join
- Disseminated cancer,
- Ongoing acute inflammation of the gallbladder,
- Known connective tissue disease,
- Cortisone medication,
- BMI \>35,
- Clinically measured rectus diastasis of \>4 cm and/or concurrent abdominal wall hernia
- Patients operated for abdominal wall hernia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CAWA - Composed Abdominal Wall Analysis
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
- Conditions
- Hernia, Abdominal Wall
- Being tested
- Harvesting of biological material
- Keywords
- hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting of biological materialProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Harvesting of study samples during planned intervention | 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. Receives: Procedure: Harvesting of biological material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Five years from enrollment
Secondary outcomes (1)
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?
Measured: Five years from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Apr 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Västerbotten
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717061
- Sponsor's protocol ID
- RVasterbotten
- Acronym
- CAWA
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAWA - Composed Abdominal Wall Analysis
- ClinicalTrials.gov ID
- NCT06717061
- Acronym / sponsor ID
- CAWA / RVasterbotten
- Conditions
- Hernia, Abdominal Wall
- Keywords
- hernia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region VästerbottenOther government
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harvesting of study samples during planned intervention | – | Procedure: Harvesting of biological materialPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Individuals seeking planned care for surgery on their gallbladder due to gallstone disease
Key exclusion criteria (7 listed)
- Disseminated cancer,
- Ongoing acute inflammation of the gallbladder,
- Known connective tissue disease,
- Cortisone medication,
- BMI \>35,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harvesting of biological materialDuring 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. | Procedure or surgery | Harvesting of study samples during planned intervention |
Primary outcome
Collagen composition differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
Time frame: Five years from enrollment
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?
1 secondary outcome
Collagen turnover differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias
Time frame: Five years from enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia and Abdominal Wall, run by Region Västerbotten at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen composition differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias (time frame: Five years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.