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

NCT ID: NCT06733571

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2024-05-12

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.

Conditions

Anastomosis, Leaking

Keywords

ANASTOTIC LEAK, DULK SCORE; DULK SCORE; LEAK

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients undergoing elective intestinal anastomosis procedures

The SMS Medical College Elective Intestinal Anastomosis Cohort is a prospective cohort study that includes patients undergoing elective intestinal anastomosis procedures at the Department of Surgery, SMS Medical College, Jaipur. This cohort consists of 86 patients who underwent various types of elective bowel reconnection surgeries, including jejuno-jejunal, ileo-ileal, ileo-colic, and colo-colic anastomoses, as well as stoma closures, between [study period]. The cohort includes both male and female patients aged 18 years and older who provided informed consent to participate.

The primary aim of this cohort study is to assess the incidence and risk factors of anastomotic leaks (AL)-a serious postoperative complication that can significantly impact patient outcomes. Detailed monitoring of preoperative conditions, surgical factors, and postoperative outcomes, the study aims to identify key risk factors associated with AL, including patient comorbidities

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sawai Mansingh Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

DARSHAN KUMAR RATHOR

Resident Doctor, Department of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Prabha OM

Role: STUDY_CHAIR

HOD DEPT OF GENERAL SURGERY

Locations

Sawai Man Singh Medical College

Jaipur, Rajasthan, India

Countries

India

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INSTITUTE

Identifier Type: OTHER

Identifier Source: secondary_id

SawaiMansinghMC

Identifier Type: -

Identifier Source: org_study_id