Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639906
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Is Preoperative Prediction of Intra-Abdominal Adhesions Possible
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can the Presence of Intra-Abdominal Adhesion Be Predicted Preoperatively
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 histopathologicallyThis study was conducted on patients who were hospitalized in the department of gynecology and obstetrics of our hospital between 01092023 and 01092024 1 year 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None