Clinical trial NCT06733571: Assessing the Validity of Dulk Score in Identifying Anastomotic Leak in Early Postoperative Period
Official title: An Observational Study on Validity of DULK Score as a Tool for Early Diagnosis of Anastomotic Leakage in the Immediate Post-Operative Period After Elective Primary Intestinal Anastomosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomosis, Leaking
Keywords: ANASTOTIC LEAK, DULK SCORE
DULK SCORE
LEAK
Lead sponsor: Sawai Mansingh Medical College
Sponsor class: OTHER_GOV
First posted: 2024-12-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study focused on patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College in Jaipur. These procedures included jejuno-jejunal, ileo-ileal anastomoses, ileo-colic and colo-colic anastomoses, as well as stoma closure. Prior to the surgeries, written informed consent was obtained from the patients. By specifically examining these elective procedures involving various types of anastomoses and stoma closure, the study aimed to investigate and analyse outcomes related to these surgical interventions within the clinical setting of the SMS Medical College in Jaipur.

Brief summary: Anastomotic leak is a commonly seen post-operative complication in patients who undergo bowel anastomosis. The outcome of which can range from conservative management to re-exteriorisation of bowel loop. This apart from financial distress can cause psychological impact on patient and his/her family. Understanding the risk factors identified, such as age, chronic diseases, anemia, and surgical variables, can aid healthcare providers in risk assessment, preoperative optimization, and postoperative monitoring to reduce the occurrence of anastomotic leaks.

By implementing strategies to address these risk factors, healthcare systems can improve patient outcomes, reduce complications, and enhance the quality of care provided to individuals undergoing surgical procedures, ultimately contributing to better public health outcomes and healthcare resource utilization.

Detailed description: Study Population This study was conducted on a cohort of 86 patients who underwent elective open intestinal anastomosis at SMS Medical College, Jaipur. The patient population consisted of 48 males (59%) and 38 females (41%). The average age of the participants was 42.68 years, with a broad age range that allowed for the analysis of age-related risk factors in relation to anastomotic leaks (AL).

Risk Factors Considered for Anastomotic Leaks (AL)

Age and Gender:

The study explored the relationship between age and the incidence of anastomotic leaks, particularly focusing on age groups above 60 years. Gender-related patterns were also assessed.

Chronic Diseases:

Patients with chronic conditions such as diabetes mellitus, hypertension, and malignancy were included to assess their role in the development of anastomotic leaks.

Immunocompromised Status:

Patients with compromised immune systems, including those undergoing chemotherapy or immunosuppressive therapy, were considered in the study.

Chronic Steroid Use:

The impact of chronic steroid use on anastomotic leak rates was evaluated.

Anemia and Hypoalbuminemia:

The study assessed anemia (hemoglobin levels \<10 g/dL) and hypoalbuminemia (serum albumin levels \<3 g/dL) as potential risk factors for anastomotic leaks.

Leukocytosis:

Leukocytosis (elevated white blood cell count) was also examined as a risk factor.

Surgical Factors Considered

Surgical Technique:

The study evaluated whether the type of surgical technique (hand-sewn vs. stapled anastomosis) influenced the occurrence of anastomotic leaks.

Location of Anastomosis:

The effect of the location of the anastomosis (e.g., distal vs. proximal) on the risk of leaks was considered.

Duration of Surgery:

The study examined whether longer surgeries (lasting over 4 hours) were associated with a higher incidence of leaks.

Surgeon Experience:

The impact of surgeon experience on leak rates was considered, focusing on procedures performed by residents versus consultants.

DULK Score and Leak Detection The DULK score, a clinical scoring system, was used in the study to predict the likelihood of an anastomotic leak in the early postoperative period. Its role in identifying high-risk patients was an important aspect of the study.

Eligibility criteria: Inclusion Criteria:1. Patients who provided informed consent to participate in the study.

2. Patients aged 18 years or older. 3. Patients who underwent elective intestinal anastomosis in a planned operation (elective OT).

4. Patients with a single-site intestinal anastomosis.

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Exclusion Criteria:1. Patients operated on in an emergency setting. 2. Patients who underwent anastomosis at multiple sites (e.g., multiple bowel resections, whipples operation).

3. Patients lost to follow-up during the post-operative period. 4. Patients who were unable or unwilling to provide informed consent. 5. Pregnant or breastfeeding women, as the study interventions may not be suitable during these periods.

6. Patients with significant cognitive impairments or psychiatric disorders that would limit their ability to understand the study protocol or provide informed consent.

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Primary outcomes:
measure: ANASTOMOTIC LEAK
timeFrame: 12 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Sawai Man Singh Medical College
state: Rajasthan
Study officials:
affiliation: HOD DEPT OF GENERAL SURGERY
name: Dr Prabha OM
role: STUDY_CHAIR
References: