CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 367 enrolled
Drug / intervention
pit-picking technique +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02712970
NCT02712970N/ACompleted

A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach

Trabzon Numune Training and Research Hospital·observational·Posted Mar 18, 2016·Updated Mar 18, 2016

In Brief

An observational study evaluating pit-picking technique, Bascom Cleft Lift, and 2 other interventions for Pilonidal Sinus. Completed, enrolled 367 participants.

Detailed Summary

A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPilonidal Sinus
Countries--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.3 years ago

Interventions

pit-picking techniqueprocedure

midline pits were excised removing a minimal amount of tissue (with a margin of skin of \<1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.

Bascom Cleft Liftprocedure

The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.

Rhomboid excision with the Limberg Flapprocedure

The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture

Other flap techniquesprocedure

Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty