Gastrointestinal CancersNCT07098871
Predictive Value of Preoperative Rectus and Diaphragm Muscle Thickness for Postoperative Complications in Gastrointestinal Cancer Surgery
An observational study of Gastrointestinal Cancers and Complication, run by Ankara Oncology Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancers, Complication
- What is being tested?
- Ultrasonography (Rectus and diaphragma muscle thickness measurement)
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Mar 2026
- How long will I take part?
- 30 Days
- 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: Patients with operable gastrointestinal system cancer from tertiary cancer center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Oncology Training and Research Hospital
Ankara, 06200
About this study
Official title: The Role of Preoperative Rectus Abdominis and Diaphragm Muscle Thickness in Predicting Postoperative Complications in Patients Undergoing Surgery for Gastrointestinal Malignancies: A Prospective Observational Study
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.
Read the detailed description
Background and Aim:
Gastrointestinal system (GIS) malignancies are commonly encountered and carry a significant risk of serious complications following surgery. Therefore, several studies in the literature have focused on identifying parameters that can predict the risk of postoperative complications in patients undergoing surgery for GIS malignancies. Some publications have suggested that preoperative nutritional indices may help predict the development of complications, evaluating specific parameters through biochemical tests or radiological assessments of muscle and fat mass.
In our study, we aim to investigate the relationship between preoperative rectus abdominis and diaphragm muscle thickness-measured via ultrasonography during routine fascial block procedures-and the rate of complications occurring within the first 30 days postoperatively in patients undergoing surgery for GIS malignancies.
Methodology:
Patients whose rectus abdominis and diaphragm muscle thickness were measured during routine preoperative fascial block ultrasonography will be included in the study. No additional intervention or procedure is planned; patients will be evaluated as part of standard clinical practice, and their postoperative outcomes will be recorded observationally. No additional tests requiring reimbursement from the national health insurance system will be performed as part of the study.
Study Hypotheses:
H₀ (Null Hypothesis): There is no significant difference in rectus abdominis and diaphragm muscle thickness between patients who develop complications within the first 30 days after GIS malignancy surgery and those who do not.
H₁ (Alternative Hypothesis): There is a significant difference in rectus abdominis and diaphragm muscle thickness between patients who develop complications within the first 30 days after GIS malignancy surgery and those who do not.
Data Collection Tools:
Data will be collected prospectively from routine clinical evaluations. Ultrasonographic measurements of rectus abdominis and diaphragm muscle thickness will be performed by the researchers during routine preoperative fascial block procedures. No additional tests or procedures requiring reimbursement from SGK will be performed. Patient identities and personal data will be kept confidential by the researchers, and all procedures carried out within the study will pose no additional risk to the patients.
Statistical Analysis:
Data obtained from the study will be analyzed using SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics (e.g., number, percentage, median) will be used to summarize the data. Quantitative variables will be evaluated using the t-test or Mann-Whitney U test, while categorical variables will be analyzed using the chi-square test or Fisher's exact test. The relationship between rectus and diaphragm muscle thickness and the development of complications will be assessed using receiver operating characteristic (ROC) curve analysis. A p-value of <0.05 will be considered statistically significant, and 95% confidence intervals will be reported.
- Conditions
- Gastrointestinal Cancers, Complication
- Being tested
- Ultrasonography (Rectus and diaphragma muscle thickness measurement)
- Keywords
- Gastrointestinal Cancers, Postoperative Complications, Rectus Muscle Thickness, Diaphragma Muscle Thickness
- Medical subject headings
- Gastrointestinal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography (Rectus and diaphragma muscle thickness measurement)Diagnostic test
Rectus and diaphragma muscle thickness will be measured by ultrasonography preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Patients undergone surgery for gastrointestinal system malignancies Receives: Diagnostic Test: Ultrasonography (Rectus and diaphragma muscle thickness measurement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications
Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications
Measured: 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
Measured: From enrollment to 30th postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancersStudies 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
- 129 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Ankara Oncology Research and Training Hospital
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Burak Dincer, Ankara Oncology Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098871
- Sponsor's protocol ID
- 2025-03/50
- Status last verified
- May 2026
- First submitted
- 22 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative Rectus Abdominis and Diaphragm Muscle Thickness in Predicting Postoperative Complications in Patients Undergoing Surgery for Gastrointestinal Malignancies: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07098871
- Acronym / sponsor ID
- 2025-03/50
- Conditions
- Gastrointestinal Cancers, Complication
- Keywords
- Gastrointestinal Cancers, Postoperative Complications, Rectus Muscle Thickness, Diaphragma Muscle Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ankara Oncology Research and Training HospitalResearch network
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 Aug 2025 (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 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.
Detailed description
Background and Aim:
Gastrointestinal system (GIS) malignancies are commonly encountered and carry a significant risk of serious complications following surgery. Therefore, several studies in the literature have focused on identifying parameters that can predict the risk of postoperative complications in patients undergoing surgery for GIS malignancies. Some publications have suggested that preoperative nutritional indices may help predict the development of complications, evaluating specific parameters through biochemical tests or radiological assessments of muscle and fat mass.
In our study, we aim to investigate the relationship between preoperative rectus abdominis and diaphragm muscle thickness-measured via ultrasonography during routine fascial block procedures-and the rate of complications occurring within the first 30 days postoperatively in patients undergoing surgery for GIS malignancies.
Methodology:
Patients whose rectus abdominis and diaphragm muscle thickness were measured during routine preoperative fascial block ultrasonography will be included in the study. No additional intervention or procedure is planned; patients will be evaluated as part of standard clinical practice, and their postoperative outcomes will be recorded observationally. No additional tests requiring reimbursement from the national health insurance system will be performed as part of the study.
Study Hypotheses:
H₀ (Null Hypothesis): There is no significant difference in rectus abdominis and diaphragm muscle thickness between patients who develop complications within the first 30 days after GIS malignancy surgery and those who do not.
H₁ (Alternative Hypothesis): There is a significant difference in rectus abdominis and diaphragm muscle thickness between patients who develop complications within the first 30 days after GIS malignancy surgery and those who do not.
Data Collection Tools:
Data will be collected prospectively from routine clinical evaluations. Ultrasonographic measurements of rectus abdominis and diaphragm muscle thickness will be performed by the researchers during routine preoperative fascial block procedures. No additional tests or procedures requiring reimbursement from SGK will be performed. Patient identities and personal data will be kept confidential by the researchers, and all procedures carried out within the study will pose no additional risk to the patients.
Statistical Analysis:
Data obtained from the study will be analyzed using SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics (e.g., number, percentage, median) will be used to summarize the data. Quantitative variables will be evaluated using the t-test or Mann-Whitney U test, while categorical variables will be analyzed using the chi-square test or Fisher's exact test. The relationship between rectus and diaphragm muscle thickness and the development of complications will be assessed using receiver operating characteristic (ROC) curve analysis. A p-value of <0.05 will be considered statistically significant, and 95% confidence intervals will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Diagnostic Test: Ultrasonography (Rectus and diaphragma muscle thickness measurement)Patients undergone surgery for gastrointestinal system malignancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable gastrointestinal system cancer from tertiary cancer center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Ultrasonography (Rectus and diaphragma muscle thickness measurement)Rectus and diaphragma muscle thickness will be measured by ultrasonography preoperatively. | Diagnostic test | Surgery |
Primary outcome
Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications
Time frame: From enrollment to 30th postoperative day.
Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications
Correlation between diaphragma muscle thickness and clavien-dindo grade of postoperative complications
Time frame: From enrollment to 30th postoperative day.
Correlation between diaphragma muscle thickness and clavien-dindo grade of postoperative complications
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 13 May 2026.
- Individual participant dataSharing planned: No
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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 Gastrointestinal Cancers and Complication, run by Ankara Oncology Research and Training 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 3 inclusion and 4 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 13 May 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?
Correlation between rectus muscle thickness and clavien-dindo grade of postoperative complications (time frame: From enrollment to 30th postoperative day.). The study lists 2 primary outcomes in all. 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 13 May 2026.