Colorectal Anastomosis LeakNCT07534618
Impact of Oxygen Saturation Levels on Anastomotic Leakage and Postoperative Complications in Colorectal Surgery
An observational study of Colorectal Anastomosis Leak, run by Yasir Musa Kesgin at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Anastomosis Leak
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who underwent elective or emergency colorectal resection with anastomosis between 2017 and 2021.
Who cannot join
- Age under 18 years
- Incomplete or insufficient clinical data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences
Istanbul, Bakirkoy, 34147
About this study
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.
- Conditions
- Colorectal Anastomosis Leak
- Keywords
- colorectal, anastomosis, leak, saturation, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic leak present | Anastomotic leak present | |
| Anastomotic leak not present | Anastomotic leak not present |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Anastomotic leakage
Measured: 7 days
Secondary outcomes (2)
Overall postoperative complications
Surgical site infections (SSI), ileus, pneumonia etc
Measured: 7 days
Severe complications
Re-operation, mortality, anastomotic leak, post-op bleeding etc
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal Anastomosis LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasir Musa Kesgin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yasir Musa Kesgin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534618
- Sponsor's protocol ID
- cololeaksat
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Start Date is before January 18, 2017
Publications
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.
PubMed 16249417Moller 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.
PubMed 11809253Kang 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.
PubMed 22986932McDermott 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.
PubMed 25703524Alves 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.
PubMed 11910487Sung 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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oxygen Saturation Levels on Anastomotic Leakage and Postoperative Complications in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07534618
- Acronym / sponsor ID
- cololeaksat
- Conditions
- Colorectal Anastomosis Leak
- Keywords
- colorectal, anastomosis, leak, saturation, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Yasir Musa KesginOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic leak present | – | –Anastomotic leak present |
| Anastomotic leak not present | – | –Anastomotic leak not present |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who underwent elective or emergency colorectal resection with anastomosis between 2017 and 2021.
Key exclusion criteria (2 listed)
- Age under 18 years
- Incomplete or insufficient clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anastomotic leakage
Time frame: 7 days
Anastomotic leakage
2 secondary outcomes
Overall postoperative complications
Time frame: 7 days
Severe complications
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 16249417Belda 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.
- Background: PubMed 11809253Moller 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.
- Background: PubMed 22986932Kang 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.
- Background: PubMed 25703524McDermott 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.
- Background: PubMed 11910487Alves 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.
- Background: PubMed 33538338Sung 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.
- Individual participant dataSharing planned: No. Study Start Date is before January 18, 2017
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Anastomosis Leak, run by Yasir Musa Kesgin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534618, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.