"Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries

NCT06273826 | Recruiting

• 1 other identifier: 01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan. Main Questions:

1. 1.Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.
2. 2.Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.
3. 3.Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.

Conditions

Anastomotic Leak Large Intestine; Anastomotic Leak Rectum

Keywords

Anastomotic Leak; Colorectal surgery; Mobile application; Dutch Leakage Score

Outcome Measures

Primary Outcomes (2)

• Diagnostic effectiveness of "Colorectal Leakage App".

  Measurement of sensitivity, specificity, positive predictive value and negative predictive value of the mobile application "Colorectal Leakage App".

  1 year

• Frequency of anastomotic leakage after colorectal surgeries.

  Measurement of frequency of anastomotic leakage after colorectal surgeries at the National Research Oncology Center (NROC) in Astana, Kazakhstan.

  1 year

Secondary Outcomes (5)

• Mortality within 30 days

  1 year

• Delay in the diagnosis of anastomotic leakage

  1 year

• Duration of hospital stay.

  1 year

• Number of days in the ICU.

  1 year

• Number of days between surgery and detection of AL.

  1 year

Study Arms (1)

Colorectal Leakage App group

This group comprises patients who will be monitored using the "Colorectal Leakage App" based on the Dutch leakage score for early detection of anastomotic insufficiency after colorectal surgeries.

Diagnostic Test: "Colorectal Leakage App"

Interventions

"Colorectal Leakage App" DIAGNOSTIC_TEST

The "Colorectal Leakage App" is a mobile application designed to aid in the early detection of anastomotic insufficiency after colorectal surgeries. The app is based on the Dutch Leakage Score (DLS) algorithm, which is a standardized protocol for postoperative monitoring.

Colorectal Leakage App group

Eligibility Criteria

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

Study Population

Scheduled patients with benign and malignant colorectal diseases undergoing surgical treatment, including the creation of anastomoses (ileocolic, colocolic, colorectal anastomoses), with or without a preventive stoma.

You may qualify if:

• Scheduled patients with benign and malignant colorectal diseases undergoing surgical treatment, including the creation of anastomoses (ileocolic, colocolic, colorectal anastomoses), with or without a preventive stoma.
• Male and female patients aged 18 years and older.
• ECOG = 0-2; 6. Satisfactory hematological indicators and parameters of liver and kidney function.

You may not qualify if:

• Participants under 18 years old.
• Pregnant, lactating, or planning pregnancy participants.
• ECOG\>2;
• Unresctable tumors.
• Patient's refusal to continue participating in the study..

Sponsors & Collaborators

• National Research Oncology and Transplantology Center, Kazakhstan: lead

Study Sites (1)

National Research Oncology Center

Astana, 010000, Kazakhstan

RECRUITING

Related Publications (8)

• Jutesten H, Buchwald PL, Angenete E, Rutegard M, Lydrup ML. High Risk of Low Anterior Resection Syndrome in Long-term Follow-up After Anastomotic Leakage in Anterior Resection for Rectal Cancer. Dis Colon Rectum. 2022 Oct 1;65(10):1264-1273. doi: 10.1097/DCR.0000000000002334. Epub 2021 Dec 15.

  PMID: 35482994 RESULT

• Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.

  PMID: 21394013 RESULT

• Akasu T, Takawa M, Yamamoto S, Yamaguchi T, Fujita S, Moriya Y. Risk factors for anastomotic leakage following intersphincteric resection for very low rectal adenocarcinoma. J Gastrointest Surg. 2010 Jan;14(1):104-11. doi: 10.1007/s11605-009-1067-4. Epub 2009 Oct 20.

  PMID: 19841989 RESULT

• Thornton M, Joshi H, Vimalachandran C, Heath R, Carter P, Gur U, Rooney P. Management and outcome of colorectal anastomotic leaks. Int J Colorectal Dis. 2011 Mar;26(3):313-20. doi: 10.1007/s00384-010-1094-3. Epub 2010 Nov 25.

  PMID: 21107847 RESULT

• Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.

  PMID: 22986932 RESULT

• Boccola MA, Lin J, Rozen WM, Ho YH. Reducing anastomotic leakage in oncologic colorectal surgery: an evidence-based review. Anticancer Res. 2010 Feb;30(2):601-7.

  PMID: 20332477 RESULT

• Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.

  PMID: 19228539 RESULT

• den Dulk M, Noter SL, Hendriks ER, Brouwers MA, van der Vlies CH, Oostenbroek RJ, Menon AG, Steup WH, van de Velde CJ. Improved diagnosis and treatment of anastomotic leakage after colorectal surgery. Eur J Surg Oncol. 2009 Apr;35(4):420-6. doi: 10.1016/j.ejso.2008.04.009. Epub 2008 Jun 27.

  PMID: 18585889 RESULT

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meiram Mamlin, MD

  National Research Oncology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saule Khamzina, MD

CONTACT

+77757172961; khamzina.saule88@gmail.com

Arman Kozhakhmetov, MD

CONTACT

+77772714801; a.kozhakhmetov@nu.edu.kz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the colorectal division.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: January 19, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

KA (1)