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Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus

Evaluation of Rhomboid Flap Outcome in the Surgical Treatment of Recurrent Sacrococcygeal Pilonidal Sinus vs. Deep Suturing

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06152952
Enrollment
30
Registered
2023-12-01
Start date
2023-12-31
Completion date
2026-01-31
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus Infected

Keywords

Rhomboid flap, Deep suturing

Brief summary

This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.

Detailed description

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 .

Interventions

PROCEDUREThe 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

Inclusion criteria

* Adult patients aged between 18 and 60 years; * Patients with one or two small inactive sinuses will be included for easier excisional procedures; * Previous intervention for pilonidal disease whether surgical or non-surgical;

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.baselinePrimary 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

Secondary

MeasureTime frameDescription
Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.baselineSecondary 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.

Other

MeasureTime frameDescription
Data management and analysis (Details needed):baselineData 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.

Contacts

Primary ContactAhmed Dify, G.P.
Ahmeddify94@gmail.com00201022552241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026