Is Preoperative Prediction of Intra-Abdominal Adhesions Possible?

NCT06639906 | Recruiting

• 1 other identifier: MCBU-Adhesion
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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 histopathologically.This study was conducted on patients who were hospitalized in the department of gynecology and obstetrics of our hospital between 01.09.2023 and 01.09.2024 (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.

Conditions

Adhesions Abdominal; Surgery

Keywords

Intraabdominal Adhesion; Decorin; TGF β1; Gynecological Abdominal Surgery; Prediction

Outcome Measures

Primary Outcomes (2)

• 1% Patients's intraabdominal adhesion tissues while surgery. Adhesion tissues Staining will be Measured by decorin and TGF β immunohistochemistry.

  Baseline

• Patient's blood will measured by decorin and TGF β biochemistry technique.

  Baseline

Secondary Outcomes (1)

• Sociodemographic questions were measured by survey technique.

  Baseline

Study Arms (2)

Group 1:

Patients with intra-abdominal adhesions

Group 2:

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Patients with Intraabdominal Adhesions
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with Intraabdominal Adhesions

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

adhesion tissues and patient blood

Central Study Contacts

Kemal Sarsmaz, Dr.

CONTACT

05068074452; drsarsmazkemal@gmail.com

Hayrunnisa Yesil Sarsmaz, Dr.

CONTACT

05552649495; sarsmaznisa@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: January 14, 2024
• Primary Completion: October 8, 2024
• Study Completion: January 14, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)