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

NCT06733571 | Completed

• 2 other identifiers: SawaiMansinghMCINSTITUTE
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomosis, Leaking

Keywords

ANASTOTIC LEAK, DULK SCORE; DULK SCORE; LEAK

Outcome Measures

Primary Outcomes (1)

• ANASTOMOTIC LEAK

  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.

  12 DAYS

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Patients aged 18 years or older. 3. Patients who underwent elective intestinal anastomosis in a planned operation (elective OT).
• \. Patients with a single-site intestinal anastomosis.

You may not qualify if:

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

Sponsors & Collaborators

• Sawai Mansingh Medical College: lead

Study Sites (1)

Sawai Man Singh Medical College

Jaipur, Rajasthan, 302001, India

Location

Study Officials

• Dr Prabha OM

  HOD DEPT OF GENERAL SURGERY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor, Department of General Surgery

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 13, 2024
• Study Start: March 22, 2023
• Primary Completion: April 23, 2024
• Study Completion: May 12, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)