NCT06396351

Brief Summary

The authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 25, 2024

Last Update Submit

April 29, 2024

Conditions

Keywords

abdominal complianceintraabdominal pressurelaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • The factors affecting abdominal compliance

    Effect of rectus muscle thickness and lateral abdominal muscle group thickness on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

Secondary Outcomes (8)

  • The factors affecting abdominal compliance

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

  • The factors affecting abdominal compliance

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

  • The factors affecting abdominal compliance

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

  • The factors affecting abdominal compliance

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

  • The factors affecting abdominal compliance

    From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery

  • +3 more secondary outcomes

Interventions

effect of carbondioxide insufflation on abdominal compliance was evaluated

Also known as: Carbondioxide insufflation

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ASA I-III patients aged between 18 and 82 years undergoing elective abdominal surgery with laparoscopic technique.

You may qualify if:

  • Aged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique

You may not qualify if:

  • Aged below 18 and above 82 ASA IV-V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical School Anesthesiology and ICU Department

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Menekse Ozcelik

    Ankara University

    STUDY CHAIR
  • Ezgi Yıldırım

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Keziban Sanem Çakar Turhan

    Ankara University

    STUDY CHAIR
  • Aysegul Guven

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Derya Gökmen

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 2, 2024

Study Start

August 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

May 2, 2024

Record last verified: 2024-04

Locations