NCT06403540

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

May 3, 2024

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The impact of laparotomy on diaphragm thickness.

    Comparison of diaphragm muscle measurements before and after surgery

    Measurement at the 1st postoperative hour

Secondary Outcomes (1)

  • The effect of analgesia methods on diaphragm thickness in patients undergoing laparoscopic surgery.

    Measurement at the 1st postoperative hour

Study Arms (1)

diaphragm contraction fraction

Diaphragm muscle contraction fraction measured before and after surgery

Diagnostic Test: ultrasonography

Interventions

ultrasonographyDIAGNOSTIC_TEST

Using ultrasonography to measure diaphragm thickness

diaphragm contraction fraction

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for major abdominal surgery due to gastrointestinal tumor

You may qualify if:

  • over 18 years,
  • major abdominal surgery cases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 8, 2024

Study Start

January 30, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations