SarcopeniaNCT07817758
Preoperative Sarcopenia and Postoperative Outcomes in Older Patients With Gastrointestinal Cancer
An observational study of Sarcopenia and Gastrointestinal Neoplasms, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective cohort study aims to evaluate the association between preoperative sarcopenia and postoperative outcomes in patients aged 60 years or older undergoing elective surgery for gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Gastrointestinal Neoplasms
- What is being tested?
- Preoperative Sarcopenia Status
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 years or older with gastrointestinal system cancer who are scheduled to undergo elective surgery at the General Surgery Clinic of Van Training and Research Hospital.
Who may be able to join
- Age 60 years or older
- Diagnosis of gastrointestinal system cancer
- Scheduled to undergo elective surgical treatment
- Considered operable based on routine clinical evaluation
- Ability to complete the preoperative sarcopenia assessments
- Provision of written informed consent
Who cannot join
- Age younger than 60 years
- Undergoing emergency surgery
- Inability to complete the required preoperative sarcopenia assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Education and Research Hospital
Van, Van, 65300
İbrahim Doğan, MD, +905313884966, dogan_203@hotmail.com
About this study
Official title: The Effect of Preoperative Sarcopenia on Postoperative Prognosis in Older Patients With Gastrointestinal Cancer: A Prospective Cohort Study
This prospective cohort study aims to evaluate the association between preoperative sarcopenia and postoperative outcomes in patients aged 60 years or older undergoing elective surgery for gastrointestinal cancer. Sarcopenia will be assessed preoperatively using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, including muscle strength, muscle mass, and physical performance, together with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire and calf circumference measurement. Participants will be followed for 90 days after surgery. Postoperative complications, length of hospital stay, and 30-day and 90-day mortality will be evaluated.
Read the detailed description
Sarcopenia is characterized by reduced muscle strength, muscle mass, and physical performance and may be associated with unfavorable postoperative outcomes in older patients with cancer. This prospective, single-center observational cohort study will include patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer at Van Training and Research Hospital.
Before surgery, demographic and clinical characteristics, including age, sex, and cancer diagnosis, will be recorded. Sarcopenia will be evaluated according to the EWGSOP2 criteria using measurements of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed as part of the preoperative assessment.
Participants will receive standard surgical and perioperative care, and no treatment or intervention will be assigned by the study protocol. Patients will be observed for 90 days after surgery. Outcomes will include postoperative surgical complications, length of hospital stay, 30-day mortality, and 90-day mortality. Postoperative complications of interest will include anastomotic leakage, wound-related complications, oral intake intolerance, and delayed mobilization. The study will compare these outcomes between patients with and without preoperative sarcopenia and assess whether sarcopenia is independently associated with adverse postoperative outcomes.
- Conditions
- Sarcopenia, Gastrointestinal Neoplasms
- Being tested
- Preoperative Sarcopenia Status
- Keywords
- EWGSOP2, Older adults, Geriatric patients, Gastrointestinal cancer
- Medical subject headings
- Sarcopenia, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Sarcopenia StatusOther
Preoperative sarcopenia status will be determined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria using assessments of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed. No therapeutic intervention will be assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Preoperative Sarcopenia | Participants aged 60 years or older undergoing elective surgery for gastrointestinal cancer who are identified as having preoperative sarcopenia according to the EWGSOP2 criteria. Participants will receive standard surgical and perioperative care without any study-assigned intervention. Receives: Other: Preoperative Sarcopenia Status | |
| Participants Without Preoperative Sarcopenia | Participants aged 60 years or older undergoing elective surgery for gastrointestinal cancer who are not identified as having preoperative sarcopenia according to the EWGSOP2 criteria. Participants will receive standard surgical and perioperative care without any study-assigned intervention. Receives: Other: Preoperative Sarcopenia Status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
The number and percentage of participants who experience at least one postoperative complication, including anastomotic leakage, wound-related complications, oral intake intolerance, delayed mobilization, or another surgery-related complication. Complications will be identified through inpatient records and follow-up assessments.
Measured: From the date of surgery through 90 days after surgery
Secondary outcomes (3)
Length of hospital stay
The duration of postoperative hospitalization, calculated in days from the date of surgery to the date of hospital discharge.
Measured: From the date of surgery through hospital discharge, an average of 7 days
30-day all-cause mortality
The number and percentage of participants who die from any cause within 30 days after surgery.
Measured: Within 30 days after surgery
90-day all-cause mortality
The number and percentage of participants who die from any cause within 90 days after surgery.
Measured: Within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM DOGAN, Van Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817758
- Sponsor's protocol ID
- 2026-KAEK-59
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Sarcopenia on Postoperative Prognosis in Older Patients With Gastrointestinal Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07817758
- Acronym / sponsor ID
- 2026-KAEK-59
- Conditions
- Sarcopenia, Gastrointestinal Neoplasms
- Keywords
- EWGSOP2, Older adults, Geriatric patients, Gastrointestinal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Van Training and Research HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Sep 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.
This prospective cohort study aims to evaluate the association between preoperative sarcopenia and postoperative outcomes in patients aged 60 years or older undergoing elective surgery for gastrointestinal cancer. Sarcopenia will be assessed preoperatively using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, including muscle strength, muscle mass, and physical performance, together with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire and calf circumference measurement. Participants will be followed for 90 days after surgery. Postoperative complications, length of hospital stay, and 30-day and 90-day mortality will be evaluated.
Detailed description
Sarcopenia is characterized by reduced muscle strength, muscle mass, and physical performance and may be associated with unfavorable postoperative outcomes in older patients with cancer. This prospective, single-center observational cohort study will include patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer at Van Training and Research Hospital.
Before surgery, demographic and clinical characteristics, including age, sex, and cancer diagnosis, will be recorded. Sarcopenia will be evaluated according to the EWGSOP2 criteria using measurements of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed as part of the preoperative assessment.
Participants will receive standard surgical and perioperative care, and no treatment or intervention will be assigned by the study protocol. Patients will be observed for 90 days after surgery. Outcomes will include postoperative surgical complications, length of hospital stay, 30-day mortality, and 90-day mortality. Postoperative complications of interest will include anastomotic leakage, wound-related complications, oral intake intolerance, and delayed mobilization. The study will compare these outcomes between patients with and without preoperative sarcopenia and assess whether sarcopenia is independently associated with adverse postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants With Preoperative Sarcopenia | – | Other: Preoperative Sarcopenia StatusParticipants aged 60 years or older undergoing elective surgery for gastrointestinal cancer who are identified as having preoperative sarcopenia according to the EWGSOP2 criteria. Participants will receive standard surgical and perioperative care without any study-assigned intervention. |
| Participants Without Preoperative Sarcopenia | – | Other: Preoperative Sarcopenia StatusParticipants aged 60 years or older undergoing elective surgery for gastrointestinal cancer who are not identified as having preoperative sarcopenia according to the EWGSOP2 criteria. Participants will receive standard surgical and perioperative care without any study-assigned intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 years or older with gastrointestinal system cancer who are scheduled to undergo elective surgery at the General Surgery Clinic of Van Training and Research Hospital.
Key inclusion criteria (6 listed)
- Age 60 years or older
- Diagnosis of gastrointestinal system cancer
- Scheduled to undergo elective surgical treatment
- Considered operable based on routine clinical evaluation
- Ability to complete the preoperative sarcopenia assessments
Key exclusion criteria (3 listed)
- Age younger than 60 years
- Undergoing emergency surgery
- Inability to complete the required preoperative sarcopenia assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Sarcopenia StatusPreoperative sarcopenia status will be determined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria using assessments of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed. No therapeutic intervention will be assigned by the study protocol. | Other | Participants With Preoperative Sarcopenia, Participants Without Preoperative Sarcopenia |
Primary outcome
Incidence of postoperative complications
Time frame: From the date of surgery through 90 days after surgery
The number and percentage of participants who experience at least one postoperative complication, including anastomotic leakage, wound-related complications, oral intake intolerance, delayed mobilization, or another surgery-related complication. Complications will be identified through inpatient records and follow-up assessments.
3 secondary outcomes
Length of hospital stay
Time frame: From the date of surgery through hospital discharge, an average of 7 days
30-day all-cause mortality
Time frame: Within 30 days after surgery
90-day all-cause mortality
Time frame: Within 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
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 Sarcopenia and Gastrointestinal Neoplasms, run by Van Training and Research Hospital 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İbrahim Doğan, MD (+905313884966, dogan_203@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: From the date of surgery through 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.