Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus

NCT06152952 | Unknown

• 1 other identifier: pilonidal sinus
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pilonidal Sinus Infected

Keywords

Rhomboid flap; Deep suturing

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Secondary Outcomes (1)

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

  baseline

Other Outcomes (1)

• Data management and analysis (Details needed):

  baseline

Study Arms (2)

Group 1 : 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 (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

Group 2 : 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. 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

Interventions

The rhomboid flap approach PROCEDURE

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

Group 1 : The rhomboid flap Approach; Group 2 : The deep suturing approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Diversity in population, some come from a rural environment and others from the city

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 37023403 BACKGROUND

• 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.

  PMID: 32012508 BACKGROUND

• 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.

  PMID: 30440104 BACKGROUND

• 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.

  PMID: 30948198 BACKGROUND

• 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.

  PMID: 23911903 BACKGROUND

Central Study Contacts

Ahmed Dify, G.P.

CONTACT

00201022552241; Ahmeddify94@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 5, 2023

Record last verified: 2023-12