Adhesions AbdominalNCT06639906
Is Preoperative Prediction of Intra-Abdominal Adhesions Possible?
An observational study of Adhesions Abdominal and Surgery, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the presence of intra-abdominal adhesion with biochemical markers before the operation, as well as to determine whether there is a relationship between the severity of adhesion and preoperative blood decorin and TGF β1 levels by examining intra-abdominal adhesions… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adhesions Abdominal, Surgery
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2024to 1 Apr 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Adult
Study population: Patients with Intraabdominal Adhesions
Who may be able to join
- Patients who are hospitalized for gynecological reasons with a planned laparotomy or laparoscopic abdominal surgery
- Patients with at least 1 previous cesarean section or history of previous abdominal surgery (laparoscopy or laparotomy)
Who cannot join
- Patients who do not agree to participate in the study will not be included in the study.
- Pregnant patients will not be included in the study (so that the physiological changes of pregnancy do not affect the results)
- Presence of preoperative clinical or laboratory findings of infection (such as high fever, tachycardia, leukocytosis, high CRP)
- Presence of hematological or coagulation disorders
- History or presence of cancer treatment
- History or presence of connective tissue disease
- Presence of diabetes
- Being under 18 years of age will be considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Presence of Intra-Abdominal Adhesion Be Predicted Preoperatively?
In this study, it was aimed to evaluate the presence of intra-abdominal adhesion with biochemical markers before the operation, as well as to determine whether there is a relationship between the severity of adhesion and preoperative blood decorin and TGF β1 levels by examining intra-abdominal adhesions histopathologically.This study was conducted on patients who were hospitalized in the department of gynecology and obstetrics of our hospital between 14.01.2024 and 08.10.2024 with laparotomy or laparoscopic abdominal surgery planned for gynecological reasons and who had at least 1 previous cesarean section or a history of previous abdominal surgery (laparoscopy or laparotomy). will be made among patients.
The study is voluntary and patients who meet the appropriate criteria will be informed verbally and written consent will be obtained from the patients. Preoperative blood samples will be taken from each patient included in the study. Patients with no adhesions detected in the abdomen during the operation will constitute the control group, and patients with adhesions detected will constitute the study group. The number of patients is planned to be 26 patients in the case group and 28 patients in the control group. Tissue samples removed from detected intra-abdominal adhesions will be taken for histological examination. The tissue samples obtained will be subjected to routine light microscopy tissue monitoring and embedded in paraffin blocks, 5 micron sections will be taken with a microtome and will be examined with a light microscope after being stained with Hematoxylin Eosin. Adhesions detected intra-abdominally are according to the "peritoneal adhesion index" classification; It will be graded in 4 stages: 0: No adhesion, 1: Thin adhesions, blunt dissection, 2: Dense adhesions, sharp dissection, 3: Dense dense and vascularized adhesions, sharp dissection, injury that can be prevented with difficulty. Thanks to the grading of intra-abdominal adhesions, it will be possible to evaluate not only whether the parameters examined are predictive of intra-abdominal adhesions, but also which degree of adhesions they are more effective in predicting. Whether the presence of intra-abdominal adhesion is predictable will be determined by comparing the decorin and TGF β biomarker levels in preoperative blood samples with the decorin and TGF β immunohistochemistry results in the adhesion tissue.
- Conditions
- Adhesions Abdominal, Surgery
- Keywords
- Intraabdominal Adhesion, Decorin, TGF β1, Gynecological Abdominal Surgery, Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Patients with intra-abdominal adhesions | |
| Group 2: | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1% Patients's intraabdominal adhesion tissues while surgery. Adhesion tissues Staining will be Measured by decorin and TGF β immunohistochemistry.
Measured: Baseline
Patient's blood will measured by decorin and TGF β biochemistry technique.
Measured: Baseline
Secondary outcomes (1)
Sociodemographic questions were measured by survey technique.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Jan 2024
- Primary completion8 Oct 2024
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesions AbdominalStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639906
- Sponsor's protocol ID
- MCBU-Adhesion
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Presence of Intra-Abdominal Adhesion Be Predicted Preoperatively?
- ClinicalTrials.gov ID
- NCT06639906
- Acronym / sponsor ID
- MCBU-Adhesion
- Conditions
- Adhesions Abdominal, Surgery
- Keywords
- Intraabdominal Adhesion, Decorin, TGF β1, Gynecological Abdominal Surgery, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 15 Oct 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.
In this study, it was aimed to evaluate the presence of intra-abdominal adhesion with biochemical markers before the operation, as well as to determine whether there is a relationship between the severity of adhesion and preoperative blood decorin and TGF β1 levels by examining intra-abdominal adhesions histopathologically.This study was conducted on patients who were hospitalized in the department of gynecology and obstetrics of our hospital between 14.01.2024 and 08.10.2024 with laparotomy or laparoscopic abdominal surgery planned for gynecological reasons and who had at least 1 previous cesarean section or a history of previous abdominal surgery (laparoscopy or laparotomy). will be made among patients.
The study is voluntary and patients who meet the appropriate criteria will be informed verbally and written consent will be obtained from the patients. Preoperative blood samples will be taken from each patient included in the study. Patients with no adhesions detected in the abdomen during the operation will constitute the control group, and patients with adhesions detected will constitute the study group. The number of patients is planned to be 26 patients in the case group and 28 patients in the control group. Tissue samples removed from detected intra-abdominal adhesions will be taken for histological examination. The tissue samples obtained will be subjected to routine light microscopy tissue monitoring and embedded in paraffin blocks, 5 micron sections will be taken with a microtome and will be examined with a light microscope after being stained with Hematoxylin Eosin. Adhesions detected intra-abdominally are according to the "peritoneal adhesion index" classification; It will be graded in 4 stages: 0: No adhesion, 1: Thin adhesions, blunt dissection, 2: Dense adhesions, sharp dissection, 3: Dense dense and vascularized adhesions, sharp dissection, injury that can be prevented with difficulty. Thanks to the grading of intra-abdominal adhesions, it will be possible to evaluate not only whether the parameters examined are predictive of intra-abdominal adhesions, but also which degree of adhesions they are more effective in predicting. Whether the presence of intra-abdominal adhesion is predictable will be determined by comparing the decorin and TGF β biomarker levels in preoperative blood samples with the decorin and TGF β immunohistochemistry results in the adhesion tissue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: | – | –Patients with intra-abdominal adhesions |
| Group 2: | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients with Intraabdominal Adhesions
Key inclusion criteria (2 listed)
- Patients who are hospitalized for gynecological reasons with a planned laparotomy or laparoscopic abdominal surgery
- Patients with at least 1 previous cesarean section or history of previous abdominal surgery (laparoscopy or laparotomy)
Key exclusion criteria (8 listed)
- Patients who do not agree to participate in the study will not be included in the study.
- Pregnant patients will not be included in the study (so that the physiological changes of pregnancy do not affect the results)
- Presence of preoperative clinical or laboratory findings of infection (such as high fever, tachycardia, leukocytosis, high CRP)
- Presence of hematological or coagulation disorders
- History or presence of cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1% Patients's intraabdominal adhesion tissues while surgery. Adhesion tissues Staining will be Measured by decorin and TGF β immunohistochemistry.
Time frame: Baseline
Patient's blood will measured by decorin and TGF β biochemistry technique.
Time frame: Baseline
1 secondary outcome
Sociodemographic questions were measured by survey technique.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
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 Adhesions Abdominal and Surgery, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 15 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1% Patients's intraabdominal adhesion tissues while surgery. Adhesion tissues Staining will be Measured by decorin and TGF β immunohistochemistry. (time frame: Baseline). The study lists 2 primary outcomes in all. 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 15 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.