- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07763379
THE ROLE OF C-REACTIVE PROTEIN (CRP) IN THE EARLY DIAGNOSIS OF ANASTOMOTIC LEAKAGE FOLLOWING PRIMARY REPAIR IN GASTROINTESTINAL SURGERY
Despite advancements in surgical procedures, Anastomotic leakage (AL) remains a common complication following gastrointestinal surgery. It carries a high rate of morbidity and mortality, increases the cost of treatment, and leads to further interventions and delayed recovery. As surgical practice advances, AL becomes a significant obstacle for gastrointestinal surgeons worldwide (Smith et al., 2023).
The rate of AL depends on the type of operation, the location of the anastomosis, the disease itself, the method of surgery, and patient-related factors. Patient factors that contribute to AL include malnutrition, diabetes mellitus, smoking, obesity, steroid use, emergency operations, and poor blood flow to tissues (Johnson and Lee, 2024).
Even though AL begins with a small lesion in the area of the anastomosis, it can lead to extensive intra-abdominal sepsis, multiple organ failure, and death due to late diagnosis. Furthermore, in cases of oncological surgery, AL can negatively impact long-term outcomes because of delay in adjuvant treatment and increased recurrence (Brown et al., 2025).
Early identification of AL is quite challenging because postoperative symptoms are nonspecific and may resemble the common inflammatory reaction after major surgery. Symptoms including fever, tachycardia, abdominal pain, ileus, leukocytosis, or purulent drainage usually become visible only when the condition is already at an advanced stage. Radiologic tests including contrast-enhanced CT are effective methods in identifying complications. However, using these techniques in every patient after major surgery is neither feasible nor economical, and some early cases may be overlooked (Wilson et al., 2023).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mahmoud Elsayed Hussein, resident
- Telefonnummer: +201151575156
- E-mail: Mahmoud.hussin@med.sohag.edu.eg
Studiesteder
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Sohag Governorate
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Sohag, Sohag Governorate, Egypten, 82516
- Rekruttering
- Sohag University
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Kontakt:
- Sohag University
- Telefonnummer: 0934602963
- E-mail: ethics@med.sohag.edu.eg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients having surgery for abdominal gastrointestinal disorders (esophageal- Gastric- small bowel -colon ) where a primary repair or anastomosis is performed such (pathological -traumatic )
- Patients fit for surgery
- Patients who provide informed written consent.
Exclusion Criteria:
1- Patients younger than 18 years. 2. Patients with pre-existing systemic infection or sepsis outside GIT 3. Patients with liver cirrhosis affecting CRP synthesis. 4. Patients receiving corticosteroids or immunosuppressive therapy. 5. Patients refusing participation in the study 6. Post operative wound infection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
THE ROLE OF C-REACTIVE PROTEIN (CRP) IN THE EARLY DIAGNOSIS OF ANASTOMOTIC LEAKAGE FOLLOWING PRIMARY
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evaluate the role of postoperative CRP levels in the early diagnosis of anastomotic leakage after primary repair in gastrointestinal surgery. Additionally, the clinical utility of using serial CRP measurements as a simple, accessible, and cost-effective aid in the clinical management of patients. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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determine the role of CRP in early diagnosis of anastomotic leakage after gastrointestinal surgery
Tidsramme: 7 days
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7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- J Clin Med. 2024;13(7):2055
- updated review. World J Gastrointest Surg. 2024;16(2):88-97
- Ann Surg. 2023;278(4):512-520
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Soh-Med-26-7-6MS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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