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RecruitingNCT06403540Updated Apr 30, 2025

The Impact of Laparotomy and Analgesia Methods on Diaphragm

An observational study in Colorectal Neoplasms and Gastrectomy, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Colorectal Neoplasms
  • Gastrectomy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 90 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 84 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients scheduled for major abdominal surgery due to gastrointestinal tumor

Inclusion criteria

  • over 18 years,
  • major abdominal surgery cases

Exclusion criteria

Exclusion Criteria:

  • body mass index (BMI) >35 kg/m2
  • illiteracy,
  • communication issues,
  • neuromuscular disorders,
  • Advanced chronic respiratory disease,
  • Previous abdominal or thoracic surgery
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • diaphragm contraction fraction

    Diaphragm muscle contraction fraction measured before and after surgery

    Diagnostic Test: ultrasonography

Interventions

  • Diagnostic testultrasonography

    Using ultrasonography to measure diaphragm thickness

06

What researchers measure

Primary outcomes

  1. The impact of laparotomy on diaphragm thickness.

    Comparison of diaphragm muscle measurements before and after surgery

    Time frame: 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

    Time frame: Measurement at the 1st postoperative hour

07

Study locations

1 of 1 sites recruiting
  • Prof. Dr. Cemil Taşcıoğlu City Hospital
    Istanbul, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06403540
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Fethi Gultop (Principal Investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Principal investigator
First posted
May 8, 2024
Start date
Jan 30, 2025
Primary completion
Jul 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Apr 30, 2025

Study contacts

fethi gültop
Contact
fethigultop@yahoo.com
+905052260067

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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