minimal invasive pilonidal cystotomy for Pilonidal Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Naval Medical Center Portsmouth, Portsmouth, VA
Pilonidal Disease
minimal invasive pilonidal cystotomy - Procedure
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a minimally invasive procedure for pilonidal disease is as effective as a more invasive procedure.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether minimal invasive pilonidal cystotomy will improve 1 primary outcome and 2 secondary outcomes in patients with Pilonidal Disease. Measurement will happen over the course of 30 days.

2 years
Rate of early recurrence
30 days
Patient satisfaction
Tolerance of the procedure

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Minimal invasive pilonidal cystotomy
1 of 2
Open traditional pilonidal cystectomy
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 106 total participants across 2 different treatment groups

This trial involves 2 different treatments. Minimal Invasive Pilonidal Cystotomy is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Minimal invasive pilonidal cystotomy
Procedure
Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity
Open traditional pilonidal cystectomy
Procedure
traditional complete wide-excision pilonidal cystectomy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Naval Medical Center Portsmouth - Portsmouth, VA

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All patients who are scheduled for elective surgical treatment for their pilonidal disease

Patient Q&A Section

What are common treatments for pilonidal disease?

"This review highlights that a substantial proportion of NTD affected individuals may become non-communicable diseases through the consequences of untreated infections such as those of onchocerciasis (River blindness) and ascariasis (Diva-Dry Eye). NTD are treated by applying topical and systemic antimicrobials. Antibiotics (for example, i.v. amoxicillin or macrolides) are used for many infections such as onchocerciasis, ascariasis and cysticercosis. Praziquantel is the drug recommended by the World Health Organization due to its low cost and easy availability. There are no effective vaccines for NTD." - Anonymous Online Contributor

Unverified Answer

Can pilonidal disease be cured?

"There is no data supporting a method of cure for the disease, and the current evidence on the subject is limited to anecdotal cure claims." - Anonymous Online Contributor

Unverified Answer

What causes pilonidal disease?

"Pilonidal disease does not appear to have an infectious or hereditary cause. There may be a genetic linkage to pilonidal sinus. The aetiology appears to be multifactorial with a probable link to the pilosebaceous unit." - Anonymous Online Contributor

Unverified Answer

How many people get pilonidal disease a year in the United States?

"Since at least a decade, the CDC has reported a high rate of PD; however, no study had been conducted before 2005. The present study demonstrates an even higher rate, likely because of the longer average study period that exceeded the time frame used for previous studies. The rate of 0.05% (1.45/100,000) observed in the present study is approximately 2- to 3-fold higher than previous estimates. It is important to note that this rate is still slightly below the incidence of PD in Africa (1.6/100,000), but in recent years rates of PD have increased on the continent." - Anonymous Online Contributor

Unverified Answer

What is pilonidal disease?

"Pilonidal disease is a chronic infection affecting the hair-follicle region of the skin resulting in the formation of nodules over the hair-follicle with infected hair which can detach and penetrate the layer of skin. The disease can be localized and may be asymptomatic as in pilonidal abscess in which case the disease is usually managed with careful skin healing and trimming of affected hair. In chronic case pilonidal scab may develop and lead to skin deterioration and in extreme cases pilonidal disease may penetrate the deep layers of skin resulting in cellulitis or abscess formation. To manage this case a well-planned and gentle medical evacuation with appropriate isolation and cleaning of the wound is required." - Anonymous Online Contributor

Unverified Answer

What are the signs of pilonidal disease?

"Signs include discharge from the site, presence of a fistula, sinuses, bony enlargement and hard masses. All of these are typical signs and manifestations of pilonidal disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating pilonidal disease?

"Despite advances in modern treatment, more than half of pilonidal disease patients still has not recovered in the first 6 months. Moreover, one-half of the patients still needed recurrence surgeries. To find the best and more effective treatments with less recurrence rate." - Anonymous Online Contributor

Unverified Answer

Is minimal invasive pilonidal cystotomy typically used in combination with any other treatments?

"MIP is commonly used in conjunction with other treatments for patients with pilonidal disease. The addition of MIP did not offer significant advantages over surgery alone. For appropriately selected patients, MIP can be considered an effective approach in treating pilonidal disease." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for pilonidal disease?

"There are clinical trials for pilonidal disease in many countries worldwide, but there are many barriers in the procedure of undertaking these trials. For a better understanding and treatment of pilonidal diseases, we need to eliminate barriers. Those in developed countries can consider clinical trials for pilonidal disease. For those who are in developing countries, clinical trials should be encouraged to decrease the prevalence of pilonidal disease." - Anonymous Online Contributor

Unverified Answer

What does minimal invasive pilonidal cystotomy usually treat?

"Minimal invasive pilonidal cystotherapies were successful in 92.1% of all patients, whereas recurrence rate was 0%. Minimal invasive pilonidal cystotomy can be considered a treatment option in recurrent and difficult to treat cases but not necessarily in the first treatment step as this procedure has to overcome multiple surgical difficulties. There is no difference in terms of complications compared with traditional pilonidal cystectomy. More studies are needed to study minimal invasive pilonidal cystotherapy in other locations." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pilonidal disease?

"Average age of infection was determined as 18.83 years for both genders. But pilonidal disease, especially on males, presents in various races, ethnicity, ages, and ages of infection." - Anonymous Online Contributor

Unverified Answer

How does minimal invasive pilonidal cystotomy work?

"Although MIPC is currently the standard treatment technique even for larger cysts and larger cases, our results confirmed that MIPC can work equally well. However, one problem with MIPC is the high rate of recurrence. In all our cases, one or two operations were required to eliminate the cyst. We therefore strongly recommend a multidisciplinary panel discussion for this issue." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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