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Status unknownNCT03931759Updated May 2, 2019

The Effect of Intra-abdominal Pressure

An interventional study of laparoscopic surgery in Diabetes Mellitus, ASA Triad and Cardiac Autonomic Neuropathy, sponsored by Erzincan University. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-05-02.

Sponsored by Erzincan University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The Effect of Intra-abdominal Pressure

Read the detailed description

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

02

Conditions studied

  • Diabetes Mellitus
  • ASA Triad
  • Cardiac Autonomic Neuropathy

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Keywords

  • diabetes mellitus
  • cardiac autonomic neuropathy
  • laparoscopic surgery
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 130 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Erzincan University is the lead sponsor of 42 studies on the registry; 5 are open to participants now.

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

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diabetes mellitus
  • laparoscopic surgery

Exclusion criteria

Exclusion Criteria:

  • hypertension
  • hearth failure
  • renal failure
  • hepatic failure
  • difficult intubation
  • shock
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Active comparator
    Diabetes mellitus

    patients with diabetes mellitus

    Diagnostic Test: laparoscopic surgery

  • No intervention
    non-Diabetes mellitus

    patients without diabetes mellitus

Interventions

  • Diagnostic testlaparoscopic surgery

    patients with diabetes mellitus in laparoscopic surgery

    Also known as: hearth rate variability

06

What researchers measure

Primary outcomes

  1. The measurement of heart rate variability in laparoscopic surgeries

    The measurement of heart rate variability is used as a method to assess the autonomic nerve system. As the autonomic nerve system dysfunction may complicate the possible peroperative problems in the patients to be operated, the pre-assessment of the autonomic nerve system function should be considered as an acquisition required to be obtained in the daily anesthesia practice. When we increase the intraabdominal pressure during the laparoscopic surgery, we think that the hemodynamic responses of the diabetic patient group, especially the patients with autonomic neuropathy, to this increasing intraabdominal pressure will be different. The aim of the present study is to investigate the effect of the intraabdominal pressure, applied to the patients diagnosed with diabetes mellitus who will have laparoscopic surgery, on hemodynamics.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03931759
Lead sponsor
Erzincan University
Responsible party
Nurhan EREN (research assistant, Erzincan University) — Principal investigator
First posted
Apr 30, 2019
Start date
Jun 2019 (estimated)
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
May 2, 2019

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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