search
Back to results

Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Primary Purpose

Pilonidal Sinus

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Primary closure
Fistulectomy
Sponsored by
Dimitri Christoforidis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pilonidal cyst requiring surgery
  • Signed Informed Consent Form

Exclusion Criteria:

  • Abnormal lesions
  • Injuries requiring a closing with rotation flap

Sites / Locations

  • Ospedale Regionale di Lugano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary closure

Fistulectomy

Arm Description

Excision of sinus and paramedian closure according to modified Karydakis technique

Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention

Outcomes

Primary Outcome Measures

Complete healing
percentage of complete healing

Secondary Outcome Measures

Time to recovery
Time to completely recovery
percentage of relapse
percentage of relapse after surgery

Full Information

First Posted
August 17, 2017
Last Updated
September 1, 2017
Sponsor
Dimitri Christoforidis
search

1. Study Identification

Unique Protocol Identification Number
NCT03271996
Brief Title
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
Official Title
Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dimitri Christoforidis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
Detailed Description
This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy) Group A: excision and paramedian closure according to modified Karydakis technique Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary closure
Arm Type
Experimental
Arm Description
Excision of sinus and paramedian closure according to modified Karydakis technique
Arm Title
Fistulectomy
Arm Type
Experimental
Arm Description
Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
Intervention Type
Procedure
Intervention Name(s)
Primary closure
Intervention Description
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
Intervention Type
Procedure
Intervention Name(s)
Fistulectomy
Intervention Description
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
Primary Outcome Measure Information:
Title
Complete healing
Description
percentage of complete healing
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Time to recovery
Description
Time to completely recovery
Time Frame
12 months
Title
percentage of relapse
Description
percentage of relapse after surgery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pilonidal cyst requiring surgery Signed Informed Consent Form Exclusion Criteria: Abnormal lesions Injuries requiring a closing with rotation flap
Facility Information:
Facility Name
Ospedale Regionale di Lugano
City
Lugnao
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32144531
Citation
Popeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6. Erratum In: Int J Colorectal Dis. 2020 May 26;:
Results Reference
derived

Learn more about this trial

Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

We'll reach out to this number within 24 hrs