Clinical trial NCT06152952: Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus
Official title: Evaluation of Rhomboid Flap Outcome in the Surgical Treatment of Recurrent Sacrococcygeal Pilonidal Sinus vs. Deep Suturing
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pilonidal Sinus Infected
Keywords: Rhomboid flap
Deep suturing
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diversity in population, some come from a rural environment and others from the city

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
timeFrame: baseline
Secondary outcomes:
measure: Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
timeFrame: baseline
Other outcomes:
measure: Data management and analysis (Details needed):
timeFrame: baseline
Locations:
Study officials:
References:
citation: Esposito C, Cerulo M, Esposito G, Turco A, Borgogni R, Carulli R, Di Mento C, Del Conte F, Coppola V, Escolino M. Endoscopic Treatment of Pilonidal Sinus Disease in Children: A Systematic Review. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):512-517. doi: 10.1089/lap.2022.0564. Epub 2023 Apr 6.
citation: Konoplitskyi V, Shavliuk R, Dmytriiev D, Dmytriiev K, Kyrychenko O, Zaletskyi B, Olkhomiak O. Pilonidal disease: changes in understanding of etiology, pathogenesis and approach to treatment. Wiad Lek. 2019 Aug 31;72(8):1559-1565.
citation: Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
citation: Grabowski J, Oyetunji TA, Goldin AB, Baird R, Gosain A, Lal DR, Kawaguchi A, Downard C, Sola JE, Arthur LG, Shelton J, Diefenbach KA, Kelley-Quon LI, Williams RF, Ricca RL, Dasgupta R, St Peter SD, Somme S, Guner YS, Jancelewicz T. The management of pilonidal disease: A systematic review. J Pediatr Surg. 2019 Nov;54(11):2210-2221. doi: 10.1016/j.jpedsurg.2019.02.055. Epub 2019 Mar 19.
citation: de Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1.