NCT02317510

Brief Summary

The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

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

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 23, 2015

Completed
Last Updated

March 15, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

December 11, 2014

Results QC Date

May 17, 2015

Last Update Submit

February 17, 2016

Conditions

Gall Stone DiseasePolyp

Keywords

Combined anesthesiaGeneral anesthesiaLaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • Duration of Operation

    group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes

    up to 2 hours

  • Post-operative Shoulder Pain

    Group 1 and Group 2 Post-operative shoulder pain

    from end of the operation to postoperative 3 days

Secondary Outcomes (10)

  • Duration of Anaesthesia

    up to 2 hours

  • Post-operative Abdominal Pain 2nd Hour

    pain at postoperative 2nd hour

  • Post-operative Abdominal Pain 4th Hour

    pain at postoperative 4th hour

  • Post-operative Abdominal Pain 6th Hour

    pain at postoperative 6th hour

  • Post-operative Abdominal Pain 12th Hour

    pain at postoperative 12th hour

  • +5 more secondary outcomes

Study Arms (2)

group 1

ACTIVE COMPARATOR

Laparoscopic cholecystectomy in General Anesthesia

Procedure: combined anesthesia

group 2

ACTIVE COMPARATOR

Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).

Procedure: general anesthesia

Interventions

combined anesthesiaPROCEDURE

Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy

group 1
general anesthesiaPROCEDURE

General anesthesia for laparoscopic cholecystectomy

group 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gall stone disease, polyp

You may not qualify if:

  • Gall bladder cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

Location

Related Publications (1)

  • Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11.

    PMID: 22686181BACKGROUND

MeSH Terms

Conditions

Polyps

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Limitations and Caveats

one patients had dural injury. Because of this that patient had released.

Results Point of Contact

Title
Dr. Turgut Donmez
Organization
Lutfiye NBGH
surgeont73@hotmail.com
00905347400967

Study Officials

  • Turgut Donmez, operator MD

    Lutfiye NBGH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, General Surgeon

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 16, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

March 15, 2016

Results First Posted

July 23, 2015

Record last verified: 2016-02

Locations

TU(1)