跳至主要内容
临床试验/NCT03424057
NCT03424057已完成不适用

A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.

Siverek Devlet Hastanesi0 个研究点目标入组 100 人开始时间: 2015年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Early postoperative complications.

研究概览

简要总结

The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

详细描述

All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between age of 18-65 who had chronic pilonidal disease

排除标准

  • Patients who did not accept the procedure
  • Patients had undergone previous pilonidal sinus surgery
  • Patientshad active infection
  • Patients who were not minimum of 18 years of age

研究组 & 干预措施

Group 1

Experimental

Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision).

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

干预措施: Asymmetric Primary Closure and Additional Skin Excision Technique (Procedure)

Group 2

Active Comparator

Group 2 were treated with the standard Karydakis technique.

干预措施: Standard Karydakis technique. (Procedure)

结局指标

主要结局

Early postoperative complications.

时间窗: 3 years

wound dehiscence, formation of seroma, hematoma, wound infection

次要结局

未报告次要终点

研究者

发起方
Siverek Devlet Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulcabbar Kartal

General surgeon

Siverek Devlet Hastanesi

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