An interventional study of surgery in Pilonidal Sinus, sponsored by Mansoura University. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 101 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The group in which the pits location were in midline ,underwent excision with primary closure
Procedure: surgery
in which more lateral pits and pits located \<2cm from mid line natal cleft
Procedure: surgery
in which more lateral pits and pits located \>2cm from mid line natal cleft
Procedure: surgery
surgery with primary closure, Rhomboid flap , or Rotational flap
Also known as: surgical procedure
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
Time frame: 6 months
Recurrence rate
how many cases developed recurrence
Time frame: 6 months - 1 year
the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.
complication rate
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Jun 2020, 65 months.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 65 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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