An observational study in Pilonidal Sinus Infected, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Assiut University · Observational
This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Pilonidal disease derives its name from Latin- pilus meaning "hair," and nidus meaning "nest" . The source of pilonidal disease is thought to be a deep intergluteal sulcus. It is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site .
Pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. Infection or abscess requires incision and drainage. Definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. Surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. Defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention .
The most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% .
The surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. In case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 30 is below the median of 145 across 37 observational studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Diversity in population, some come from a rural environment and others from the city
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Exclusion Criteria:
1 - Patients with an acute abscess. 2- Patients with mall inactive pilonidal sinus disease. 3- Age beyond the previous limits. 4- Patients with primary pilonidal disease. 5- Refusal to participate in the study. 6- Unfit for anaesthesia and surgery. 7- Patients with malignant neoplasms or inflammatory bowel disease.
The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers (gluteal fascia with 2/0 Vicryl, subcutaneous fat with 3/0 Vicryl, and the skin with 4/0 Prolene). As all sides will be equal in length, the flap fits in place without tension. A suction drain will be left behind and the wound will be dressed as usual. Pressure wound dressing will be applied and removed on the third postoperative day.
Procedure: The rhomboid flap approach
A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. Tension will be released by a limited sharp dissection above the fascia. After haemostasis is ensured using electrocautery, a suction drain will be inserted through a separate incision, then the deep fascia will be approximated and the wound will be closed in layers using polyglactin 0 sutures. Finally, the skin will be closed with 2/0 polypropylene interrupted mattress sutures.
Procedure: The rhomboid flap approach
The rhomboid flap Approach : The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers The deep suturing approach : A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. T then the deep fascia will be approximated and the wound will be closed
Also known as: The deep suturing approach
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Primary Outcome : Postoperative recurrence rate. Recurrence will be defined as the additional outbreak of signs and symptoms of pilonidal disease after a disease-free interval following complete wound healing
Time frame: baseline
Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Secondary Outcome (subsidiary): 1. Operative time. 2. Postoperative pain. 3. The incidence of other complications. 4. Postoperative cosmetic outcome. 5. The duration to walk, sit on toilet free from pain. 6. The duration till complete daily activities.
Time frame: baseline
Data management and analysis (Details needed):
Data collection Data will be collected by the principal investigator from Assiut University Hospital from. Computer software We will use SPSS version 26 for analyzing the data. Statistical tests Quantitative data will be presented as means ± SD. Categorical and binary variables will be tested using the χ 2 test and Fisher's exact test. Statistical significance will be assumed when p \< 0.05.
Time frame: baseline
No study locations are listed for this record.
Start is estimated for Dec 2023; primary completion for Jan 2026, 25 months later.
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This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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