Colorectal NeoplasmsNCT06403540
The Impact of Laparotomy and Analgesia Methods on Diaphragm
An observational study of Colorectal Neoplasms and Gastrectomy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Major abdominal surgeries are traditionally performed via laparotomy. Analgesia is routinely administered during the postoperative period. The goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Gastrectomy
- What is being tested?
- ultrasonography
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 1 Sep 2025
- 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
- Adult, Older adult
Study population: Patients scheduled for major abdominal surgery due to gastrointestinal tumor
Who may be able to join
- over 18 years,
- major abdominal surgery cases
Who cannot join
- body mass index (BMI) >35 kg/m2
- illiteracy,
- communication issues,
- neuromuscular disorders,
- Advanced chronic respiratory disease,
- Previous abdominal or thoracic surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
About this study
Official title: The Impact of Laparotomy and Analgesia Methods on Postoperative Diaphragm Muscle Contraction in Major Abdominal Surgeries.
Major abdominal surgeries are traditionally performed via laparotomy. Analgesia is routinely administered during the postoperative period. The goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function.
Read the detailed description
Laparotomy is typically performed through a midline incision during major abdominal surgeries. Patients have difficulty breathing deeply after surgery, particularly because of pain. Intravenous drug administration, epidural catheter placement, and abdominal plane blocks are common methods of analgesia. In this study, the investigators will measure the diaphragm muscle thickness at the xiphoid level at the anterior axillary line in the supine position in participants who underwent laparotomy before and one hour after the operation, using ultrasonography M mode during inspiration, expiration, and forced inspiration. the investigators will test the effects of analgesia methods on diaphragm contraction in participants undergoing laparotomy.
- Conditions
- Colorectal Neoplasms, Gastrectomy
- Being tested
- ultrasonography
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
Using ultrasonography to measure diaphragm thickness
| Study group | Role | What they receive |
|---|---|---|
| diaphragm contraction fraction | Diaphragm muscle contraction fraction measured before and after surgery Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of laparotomy on diaphragm thickness.
Comparison of diaphragm muscle measurements before and after surgery
Measured: Measurement at the 1st postoperative hour
Secondary outcomes (1)
The effect of analgesia methods on diaphragm thickness in patients undergoing laparoscopic surgery.
Comparison of diaphragm muscle measurements before and after surgery
Measured: Measurement at the 1st postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Jan 2025
- Primary completion15 Aug 2025
- Study completion1 Sep 2025
Why it stopped: The study was terminated prematurely because the planned sample size could not be achieved due to insufficient participant recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fethi Gultop, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403540
- Sponsor's protocol ID
- 02fg
- Status last verified
- Oct 2026
- First submitted
- 3 May 2024
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Laparotomy and Analgesia Methods on Postoperative Diaphragm Muscle Contraction in Major Abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT06403540
- Acronym / sponsor ID
- 02fg
- Conditions
- Colorectal Neoplasms, Gastrectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because the planned sample size could not be achieved due to insufficient participant recruitment.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 May 2024 (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.
Major abdominal surgeries are traditionally performed via laparotomy. Analgesia is routinely administered during the postoperative period. The goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function.
Detailed description
Laparotomy is typically performed through a midline incision during major abdominal surgeries. Patients have difficulty breathing deeply after surgery, particularly because of pain. Intravenous drug administration, epidural catheter placement, and abdominal plane blocks are common methods of analgesia. In this study, the investigators will measure the diaphragm muscle thickness at the xiphoid level at the anterior axillary line in the supine position in participants who underwent laparotomy before and one hour after the operation, using ultrasonography M mode during inspiration, expiration, and forced inspiration. the investigators will test the effects of analgesia methods on diaphragm contraction in participants undergoing laparotomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diaphragm contraction fraction | – | Diagnostic Test: ultrasonographyDiaphragm muscle contraction fraction measured before and after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for major abdominal surgery due to gastrointestinal tumor
Key inclusion criteria (2 listed)
- over 18 years,
- major abdominal surgery cases
Key exclusion criteria (6 listed)
- body mass index (BMI) >35 kg/m2
- illiteracy,
- communication issues,
- neuromuscular disorders,
- Advanced chronic respiratory disease,
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 |
|---|---|---|
| ultrasonographyUsing ultrasonography to measure diaphragm thickness | Diagnostic test | diaphragm contraction fraction |
Primary outcome
The impact of laparotomy on diaphragm thickness.
Time frame: Measurement at the 1st postoperative hour
Comparison of diaphragm muscle measurements before and after surgery
1 secondary outcome
The effect of analgesia methods on diaphragm thickness in patients undergoing laparoscopic surgery.
Time frame: Measurement at the 1st postoperative hour
Results and safety
The study was stopped early (reason given: The study was terminated prematurely because the planned sample size could not be achieved due to insufficient participant recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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. 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 Neoplasms and Gastrectomy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Oct 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 was stopped early (reason given: The study was terminated prematurely because the planned sample size could not be achieved due to insufficient participant recruitment.). Results are not available in the source record.
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?
The impact of laparotomy on diaphragm thickness. (time frame: Measurement at the 1st postoperative hour). 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 22 Oct 2026.