NCT02580500

Brief Summary

Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and epidural anesthesia techniques activity, reliability will be compared to the side effects and complications. One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia procedures.All patients has symptomatic pilonidal dermoid cyst.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

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

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

October 14, 2015

Last Update Submit

January 1, 2016

Conditions

Sinus; Dermal, Pilonidal

Keywords

Epidural anesthesiaSpinal anesthesiapilonidal dermoid sinus

Outcome Measures

Primary Outcomes (1)

  • sensory block duration(time:hour)

    group1 and group 2

    up to 6 hours

Secondary Outcomes (4)

  • Duration of operation(time:hour)

    up to 2 hours

  • Headache

    from end of the operation to postoperative 3 days

  • Nausea/Vomiting

    from end of the operation to postoperative 1 day

  • Urinary Retention

    from end of the operation to postoperative 1 day

Study Arms (2)

group 1

ACTIVE COMPARATOR

Pilonidal dermoid cyst surgery in Spinal anaesthesia

Procedure: spinal catheter

group 2

ACTIVE COMPARATOR

Pilonidal dermoid cyst surgery in Epidural anaesthesia

Procedure: epidural catheter

Interventions

epidural catheterPROCEDURE

epidural anaesthesia application for spinal catheter will be used

group 2
spinal catheterPROCEDURE

spinal anesthesia application for spinal catheter will be used

group 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • America Society of Anesthesiologist (ASA) physical score of I and II
  • the men and women over the age of 18, pilonidal sinus disease

You may not qualify if:

  • Pediatric patients
  • Pregnant women
  • Patients with bleeding disorder
  • Patients with spinal deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Muslu B, Usta B, Muslu S, Yesilay A, Gozdemir M, Sert H, Demircioglu R. Effect of locally administered lornoxicam in the management of low back pain after lumbar epidural anesthesia: a double-blind, randomized, controlled study. Minerva Anestesiol. 2009 Sep;75(9):494-7. Epub 2009 May 21.

    PMID: 19461565BACKGROUND

  • Orhon ZN, Koltka EN, Devrim S, Tufekci S, Dogru S, Celik M. Epidural anesthesia for pilonidal sinus surgery: ropivacaine versus levobupivacaine. Korean J Anesthesiol. 2015 Apr;68(2):141-7. doi: 10.4097/kjae.2015.68.2.141. Epub 2015 Mar 30.

    PMID: 25844132BACKGROUND

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Turgut Donmez, Surgeon

    Lutfiye Nuri Burat Goverment Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgut Donmez, Surgeon

CONTACT

905347400967surgeont73@hotmail.com

Vuslat Muslu Erdem, anesthetist

CONTACT

905326354139vuslatmuslu@gmail.com

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 14, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

TU(1)