NCT02568852

Brief Summary

Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of pneumoperitoneum on coagulation factors is not well known. In our study the investigators aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA) during laparoscopic cholecystectomy(LC) with effect on coagulation factors. Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.

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 Oct 2015

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

First Submitted

Initial submission to the registry

October 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

October 1, 2015

Results QC Date

February 18, 2016

Last Update Submit

May 23, 2016

Conditions

Gall Stone DiseasePolyp

Keywords

D-dimerFibrinogenLaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Duration of Operation

    group1 and group 2(Duration of Operation)

    up to 2 hours

Secondary Outcomes (15)

  • Fibrinogen Level

    pre-operative

  • Fibrinogen Level

    Post-operative 1 st hour

  • Fibrinogen Level

    Post-operative 24th hour

  • PT(Prothrombin Time)

    pre-operative

  • PT(Prothrombin Time)

    Post-operative 1st hour

  • +10 more secondary outcomes

Study Arms (2)

group 1

ACTIVE COMPARATOR

Laparoscopic cholecystectomy in general anaesthesia

Procedure: Combined anaesthesia

group 2

ACTIVE COMPARATOR

Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).

Procedure: General anaesthesia

Interventions

Combined anaesthesiaPROCEDURE

Laparoscopic cholecystectomy under 10 mmHg pressure

group 1
General anaesthesiaPROCEDURE

Laparoscopic cholecystectomy under 10 mmHg pressure

group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gall bladder stone
  • Gall bladder polyp

You may not qualify if:

  • Pregnancy
  • Malignancy
  • Children
  • Acute cholecystitis
  • Vertebral deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

Location

Related Publications (2)

  • Ntourakis D, Sergentanis TN, Georgiopoulos I, Papadopoulou E, Liasis L, Kritikos E, Tzardis P, Laopodis V. Subclinical activation of coagulation and fibrinolysis in laparoscopic cholecystectomy: do risk factors exist? Int J Surg. 2011;9(5):374-7. doi: 10.1016/j.ijsu.2011.02.011. Epub 2011 Mar 1.

    PMID: 21371576BACKGROUND

  • Frantzides CT, Welle SN, Ruff TM, Frantzides AT. Routine anticoagulation for venous thromboembolism prevention following laparoscopic gastric bypass. JSLS. 2012 Jan-Mar;16(1):33-7. doi: 10.4293/108680812X13291597716906.

    PMID: 22906327BACKGROUND

MeSH Terms

Conditions

Polyps

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Results Point of Contact

Title
Dr.Turgut Donmez
Organization
Haseki-156
surgeont73@hotmail.com
00905347400967

Study Officials

  • Turgut Donmez, Surgeon

    Lutfiye Nuri Burat Goverment Hospital

    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
General Surgeon, MD

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 6, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

June 30, 2016

Results First Posted

June 30, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

yes

Locations

TU(1)