Predictive Value of Preoperative Rectus and Diaphragm Muscle Thickness for Postoperative Complications in Gastrointestinal Cancer Surgery

NCT07098871 | Recruiting

• 1 other identifier: 2025-03/50
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the relationship between preoperative rectus abdominis and diaphragm muscle thickness and postoperative complication rates in patients undergoing surgery for gastrointestinal system malignancies. The main research question is whether rectus abdominis and diaphragm muscle thickness can be used to predict postoperative complications in these patients, and whether there are specific cut-off values for these muscle thicknesses. Participants will be selected from operable gastrointestinal malignancy cases, and preoperative measurements of rectus abdominis and diaphragm muscle thickness will be performed using ultrasonography.

Conditions

Complication; Gastrointestinal Cancers

Keywords

Gastrointestinal Cancers; Postoperative Complications; Rectus Muscle Thickness; Diaphragma Muscle Thickness

Outcome Measures

Primary Outcomes (2)

• Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications

  Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications

  From enrollment to 30th postoperative day.

• Correlation between diaphragma muscle thickness and clavien-dindo grade of postoperative complications

  Correlation between diaphragma muscle thickness and clavien-dindo grade of postoperative complications

  From enrollment to 30th postoperative day.

Study Arms (1)

Surgery

Patients undergone surgery for gastrointestinal system malignancies

Diagnostic Test: Ultrasonography (Rectus and diaphragma muscle thickness measurement)

Interventions

Ultrasonography (Rectus and diaphragma muscle thickness measurement) DIAGNOSTIC_TEST

Rectus and diaphragma muscle thickness will be measured by ultrasonography preoperatively.

Surgery

Eligibility Criteria

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

Study Population

Patients with operable gastrointestinal system cancer from tertiary cancer center

You may qualify if:

• Age over 18 years
• Patients scheduled for laparoscopic or open surgery due to GIS malignancy between 01.05.2025 and 01.11.2025
• Postoperative follow-up at our center for a minimum of 30 days

You may not qualify if:

• Age under 18 years
• Patients not undergoing surgery
• Patients undergoing surgery for indications other than GIS malignancy
• Patients with follow-up data shorter than 30 days

Sponsors & Collaborators

• Ankara Oncology Research and Training Hospital: lead

Study Sites (1)

Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Postoperative Complications

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)