Assessing the Validity of Dulk Score in Identifying Anastomotic Leak in Early Postoperative Period

Completed

• Conditions: Anastomosis, Leaking

• Registration Number: NCT06733571
• Lead Sponsor: Sawai Mansingh Medical College

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.

Study Timeline

• Study Start: 2023-03-22
• Primary Completion: 2024-04-23
• Study Completion: 2024-05-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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).

3. Patients with a single-site intestinal anastomosis.

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).

2. 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.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ANASTOMOTIC LEAK	12 DAYS	The primary outcome measure is the incidence of anastomotic leaks (AL) in patients who undergo elective intestinal anastomosis at SMS Medical College, Jaipur. AL is defined as the failure of the bowel anastomosis to properly heal, leading to the leakage of intestinal contents into the peritoneal cavity, which may result in peritonitis or sepsis. The incidence is assessed in the postoperative period, primarily within the first 12 days following surgery.

Trial Locations

Locations (1)

Sawai Man Singh Medical College; 🇮🇳 Jaipur, Rajasthan, India