Is Preoperative Prediction of Intra-Abdominal Adhesions Possible?

NCT ID: NCT06639906

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-14

Study Completion Date

2026-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Adhesions Abdominal Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1:

Patients with intra-abdominal adhesions

No interventions assigned to this group

Group 2:

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Celal Bayar University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Manisa Celal Bayar University

Manisa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kemal Sarsmaz, Dr.

Role: CONTACT

05068074452

Hayrunnisa Yesil Sarsmaz, Dr.

Role: CONTACT

05552649495

Facility Contacts

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Hayrunnisa Yesil Sarsmaz

Role: primary

05552649495

Role: backup

Other Identifiers

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MCBU-Adhesion

Identifier Type: -

Identifier Source: org_study_id

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