- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534618
Impact of Oxygen Saturation Levels on Anastomotic Leakage and Postoperative Complications in Colorectal Surgery
April 10, 2026 updated by: Yasir Musa Kesgin
The aim of the present study was to evaluate the association between postoperative oxygen saturation levels and surgical complications, with particular emphasis on anastomotic leakage, in patients undergoing elective colorectal surgery.
By doing so, we sought to clarify the clinical value of peripheral oxygen saturation (SpO₂) as a non-invasive, readily available, and cost-effective parameter in postoperative patient monitoring.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
174
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bakirkoy
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Istanbul, Bakirkoy, Turkey (Türkiye), 34147
- Bakırköy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consisted of patients who underwent elective or emergency colorectal resection with anastomosis between 2017 and 2021 in a single center.
Description
Inclusion Criteria:
- Patients who underwent elective or emergency colorectal resection with anastomosis between 2017 and 2021.
Exclusion Criteria:
- Age under 18 years
- Incomplete or insufficient clinical data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Anastomotic leak present
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Anastomotic leak not present
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anastomotic leakage
Time Frame: 7 days
|
Anastomotic leakage
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall postoperative complications
Time Frame: 7 days
|
Surgical site infections (SSI), ileus, pneumonia etc
|
7 days
|
|
Severe complications
Time Frame: 7 days
|
Re-operation, mortality, anastomotic leak, post-op bleeding etc
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.
- 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.
- Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035. Erratum In: JAMA. 2005 Dec 21;294(23):2973.
- Moller AM, Villebro N, Pedersen T, Tonnesen H. Effect of preoperative smoking intervention on postoperative complications: a randomised clinical trial. Lancet. 2002 Jan 12;359(9301):114-7. doi: 10.1016/S0140-6736(02)07369-5.
- Alves A, Panis Y, Trancart D, Regimbeau JM, Pocard M, Valleur P. Factors associated with clinically significant anastomotic leakage after large bowel resection: multivariate analysis of 707 patients. World J Surg. 2002 Apr;26(4):499-502. doi: 10.1007/s00268-001-0256-4. Epub 2002 Feb 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
April 10, 2026
First Submitted That Met QC Criteria
April 10, 2026
First Posted (Actual)
April 16, 2026
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- cololeaksat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Study Start Date is before January 18, 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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