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A Single Center Experience in the Management of Pilonidal Disease

Primary Purpose

Pilonidal Sinus

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

surgery

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring sacrococcygeal pilonidal sinus, primary closure, limberg flap, rotational flap

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both sexes aging between 18- 60 years old who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent) The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap. Exclusion Criteria: surgically unfit due to commodities. those who lost follow up

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

primary closure

Rhomboid flap group

Rotational flap group

Arm Description

The group in which the pits location were in midline ,underwent excision with primary closure

in which more lateral pits and pits located <2cm from mid line natal cleft

in which more lateral pits and pits located >2cm from mid line natal cleft

Outcomes

Primary Outcome Measures

Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.

best surgical option based on pits location

Recurrence rate

how many cases developed recurrence

Secondary Outcome Measures

the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.

complication rate

Full Information

NCT ID

NCT05892198

First Posted

May 28, 2023

Last Updated

May 28, 2023

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05892198

Brief Title

A Single Center Experience in the Management of Pilonidal Disease

Official Title

A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

Detailed Description

This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population. The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge. Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pilonidal Sinus

Keywords

sacrococcygeal pilonidal sinus, primary closure, limberg flap, rotational flap

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

primary closure

Arm Type

Active Comparator

Arm Description

The group in which the pits location were in midline ,underwent excision with primary closure

Arm Title

Rhomboid flap group

Arm Type

Active Comparator

Arm Description

in which more lateral pits and pits located <2cm from mid line natal cleft

Arm Title

Rotational flap group

Arm Type

Active Comparator

Arm Description

in which more lateral pits and pits located >2cm from mid line natal cleft

Intervention Type

Procedure

Intervention Name(s)

surgery

Other Intervention Name(s)

surgical procedure

Intervention Description

surgery with primary closure, Rhomboid flap , or Rotational flap

Primary Outcome Measure Information:

Title

Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.

Description

best surgical option based on pits location

Time Frame

6 months

Title

Recurrence rate

Description

how many cases developed recurrence

Time Frame

6 months - 1 year

Secondary Outcome Measure Information:

Title

the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.

Description

complication rate

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Single Center Experience in the Management of Pilonidal Disease

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