NCT01095536

Brief Summary

Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. Moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 6, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 28, 2010

Last Update Submit

October 4, 2010

Conditions

Shoulder PainNauseaVomiting

Keywords

laparoscopic cholecystectomy, electiveanesthesia, generalshoulder painnauseavomitinglaparoscopic cholecystectomygeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative shoulder pain and emesis

    within postoperative 24 hours

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for elective laparoscopic cholecystectomy

You may qualify if:

  • \> 21 years old,
  • Chinese patient

You may not qualify if:

  • current pregnancy,
  • patients with history of upper laparotomy,
  • inability to communicate before operation,
  • persistent emesis or shoulder pain before operation,
  • patients who converted to open cholecystectomy,
  • receiving postoperative ventilator support,
  • unstable postoperative condition or major complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, Taiwan, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Shoulder PainNauseaVomiting

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Chiu-Ming Ho, M.D., Ph.D.

    Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 28, 2010

First Posted

March 30, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 6, 2010

Record last verified: 2010-03

Locations

TW(1)