NCT07817758

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jun 2026Jul 2027

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 7, 2026

Last Update Submit

September 10, 2026

Conditions

SarcopeniaGastrointestinal Neoplasms

Keywords

EWGSOP2Older adultsGeriatric patientsGastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the date of surgery through 90 days after surgery

Secondary Outcomes (3)

  • Length of hospital stay

    From the date of surgery through hospital discharge, an average of 7 days

  • 30-day all-cause mortality

    Within 30 days after surgery

  • 90-day all-cause mortality

    Within 90 days after surgery

Study Arms (2)

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.

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.

Other: Preoperative Sarcopenia Status

Interventions

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.

Participants With Preoperative SarcopeniaParticipants Without Preoperative Sarcopenia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Age younger than 60 years
  • Undergoing emergency surgery
  • Inability to complete the required preoperative sarcopenia assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Education and Research Hospital

Van, Van, 65300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SarcopeniaGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

İbrahim Doğan, MD

CONTACT

+905313884966dogan_203@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon and Principal Investigator

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 14, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 14, 2026

Record last verified: 2026-09

Locations

TU(1)