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临床试验/NCT04017260
NCT04017260已完成不适用

Combined Open and Closed Approach for Management of Pilonidal Sinus by Special U-shaped Sutures Without Drain.

Zagazig University0 个研究点目标入组 175 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
主要终点
operative time

研究概览

简要总结

Introduction: Pilonidal sinus disease (PSD) is a common surgical disease frequently seen in the intergluteal cleft. The treatment of this problem is mainly surgical.

Aim: introduce a novel technique of combined open and closed approach for management of primary pilonidal sinus (non-recurrent) by special U-shaped sutures and compare it with other techniques as regard operative time, time of complete wound healing, postoperative pain , time to stop analgesic drugs and evaluate the result of surgery without drain.

Patients: this study was conducted on 160 patients with PSD in the sacrococcygeal region who underwent operation between December 2015 and December 2017. All cases are divided randomly into four groups each consists of 40 patients.

详细描述

  1. Introduction Pilonidal sinus disease (PSD) is a common disease seen in the intergluteal cleft. This disease is usually seen between the ages of 15 years and 35 years, and males are affected more often than females [1]. The incidence of the disease is 26/100,000 in the general population [2]. The most accepted theory for this disease development is the penetration of shed hair into the skin and is associated with inflammation, abscess and sinus formation [1]. The depth of the intergluteal sulcus, the number of loose hair, and the stiffness of the hairs play important role in the disease etiology [3]. The reason for the wide acceptance of the acquired theory may be the high recurrence rates of up to 30% even after the most radical local excisions of pilonidal disease, which suggests that a pilonidal sinus is an acquired new disease rather than the persistence of some existing sinuses [4]. Although many medical and surgical methods have been proposed for this disease management, no clear consensus about the best method of treatment has been reported so far in the literature. Medical treatment modalities include phenol, silver nitrate, and electro cauterization of the cavity .The surgical options include excising the sinus to the level of the sacrococcygeal fascia and primary closure, or leaving it to secondary healing, Z-plasty, split-skin grafting, Rhomboid flap rotation, or Karydakis flap [5]. Eradication of the pilonidal sinus through wide surgical excision is still the cornerstone of treatment, yielding good long-term results, but at the expense of postoperative complications, prolonged hospital stay and a period of off-work up to 4-8 weeks, substantial pain, sub-optimal aesthetic results and recurrence [6].

The main problem after PSD surgery is recurrence, and recurrence rates have been reported in the literature to range from 3% to 46%, depending on the technique used [7].

The aim of the present study was to analyze , evaluate and compare the short term and long term clinical results of this novel technique of combined closed and open approach for management of pilonidal sinus by special U-shaped sutures without drain, Rhomboid flap technique, Karydakis technique and open technique, an approach that allows surgeons to overcome these techniques complications. 2. Materials and methods This is a controlled clinical trial on 160 patients who had been operated on for PSD between December 2015 and December 2017 in faculty of medicine, Zagazig University, after approval from medical ethical committee. Fifteen patients were lost during the study as we cannot reach them by any way and were excluded from the study. The remaining consecutive patients were included in this prospective analysis.

The patients were divided into 4 groups: Group A: 40 patients underwent combined open and closed technique, Group B: 40 patients underwent Rhomboid flap technique, Group C: 40 patients underwent Karydakis technique and Group D: 40 patients underwent open technique and wound is left to heal with secondary intention. Patients are grouped randomizally that patient 1 went to group A and patient 2 went to group B and patient 3 went to group c and patient 4 went to group D and the process is repeated.

Time of operation, postoperative morbidity and hospital stay, and loss of work days, duration of wound healing and recurrence were analyzed. Informed consent was obtained from all individual participants included in the study.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • PSD in intergluteal region
  • between 18-35 years.
  • Also those fulfilling the diagnostic criteria of Chronic discharging sinus/sinuses in natal cleft with or without surrounding tissue inflammation and with associated pain and bleeding on clinical evaluation

排除标准

  • recurrent pilonidal sinus,
  • patients who were terminally ill, had Uncontrolled diabetics, were Immunocompromised and immunosuppressed patients,
  • had acute pilonidal abscess.

结局指标

主要结局

operative time

时间窗: intraoperative

operative time for all 4 groups are measured

infection postoperative

时间窗: 2 weeks

follow up the wound in early postoperative period

次要结局

  • postoperative recurrence(1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tamer Alsaied Alnaimy

clinical professour

Zagazig University

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