NCT01826955

Brief Summary

The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

February 2, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

February 2, 2013

Last Update Submit

December 22, 2015

Conditions

Pneumoperitoneum

Keywords

pneumoperitoneum, cognitive function

Outcome Measures

Primary Outcomes (1)

  • MMSE

    5 days after operation MMSE (mini-mental status exam)was recorded

    5days after end of surgery

Study Arms (2)

Open gastrectomy

patient who undergoing open gastrectomy

laparoscopic gastrectomy

patient who undergoing laparoscopic gastrectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient who undergoing laparosopic or open gastrectomy patients who have respiratory and cardiovascular disorders were excluded

You may qualify if:

  • ASA class I or II, aged 20 to 70 yrs

You may not qualify if:

  • Patients with morbid obesity (body mass index \> 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

Related Publications (1)

  • Choi SH, Lee SJ, Jung YS, Shin YS, Jun DB, Hwang KH, Liu J, Kim KJ. Nitroglycerin- and nicardipine-induced hypotension does not affect cerebral oxygen saturation and postoperative cognitive function in patients undergoing orthognathic surgery. J Oral Maxillofac Surg. 2008 Oct;66(10):2104-9. doi: 10.1016/j.joms.2008.06.041.

    PMID: 18848109BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Hyun Jeong Kwak, M.D.

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 2, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

KR(1)