NCT02852408

Brief Summary

Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

July 26, 2016

Last Update Submit

August 1, 2016

Conditions

Laparoscopic CholecystectomyPostoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale (VAS) abdominal pain scores

    Postoperative 2nd hour

  • Visual analog scale (VAS) abdominal pain scores

    Postoperative 24th hour

Study Arms (2)

Study

liver cauterized during laparoscopic cholecystectomy.

Procedure: Laparoscopic cholecystectomy

Control

liver not-cauterized during laparoscopic cholecystectomy.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE
ControlStudy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have scheduled for laparoscopic cholecystectomy

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-II
  • Presumptive diagnosis of benign gallbladder disease

You may not qualify if:

  • The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 2, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-07