Comparison of Four Different Surgical Methods for the Treatment of Sacrococcygeal Pilonidal Sinus: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- complications
研究概览
简要总结
The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.
详细描述
Pilonidal sinus disease (PSD) is common in young adults and causes repeated infection and inflammation in the sacrococcygeal region. It is most common in men between the ages of 20 and 30, which is why most publications about PSD are part of adult series.
This study aims to determine which treatment option is more effective and beneficial for patients with sacrococcygeal pilonidal sinus. Furthermore, it aims to contribute to more positive treatment outcomes by identifying the causes of recurrence and morbidity in patients. Sacrococcygeal pilonidal sinus is quite common in adolescents. Treatment options vary from non-operative to endoscopic surgery. However, recurrence still occurs with every technique. Patients suffer from long treatment processes and morbidity. Although the exact causes of recurrence are not fully understood, it is thought that the patient's demographic characteristics and treatment option play a role. Most studies are retrospective and compare at most two treatment options. This is one of the reasons why it is not possible to reach a definitive conclusion about which treatment is more effective. Also, the number of studies conducted in the adolescent age group is limited. By conducting study prospectively and randomized, aim to prevent biased results.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having sacrococcygeal pilonidal sinus disease
- •written informed (family) consent were eligible for inclusion in this trial
排除标准
- •Being over 18 years old or under 12 years old
- •recurrent sacrococcygeal pilonidal sinus disease
研究组 & 干预措施
Crystallized Phenol Applied Group (Group P) n:21
the pilonidal sinus (PS) periphery was cleaned using an antiseptic solution. A clamp was used to widen the sinus opening. The sinuses were thoroughly cleansed. Hair and granulation tissue were removed by curettage. Nitrofurantoin pomade (FurocinR Eczacıbaşı Istanbul, Turkey) was applied around the sinus to protect it from burns. Sufficient crystallized phenol (BotaFarma Medical Ankara, Turkey) was applied to fill the cavity (approximately 3-5 gr). Because crystallized phenol liquefies as soon as it contacts the body, it was compressed with a sponge for two minutes to prevent disintegration. The sinus opening was closed with ointment. Patients were hospitalized for one day.
干预措施: Crystallized Phenol Applied (Procedure)
Endoscopy Group (Group EPSiT) n:22
The main sinus was enlarged to an initial width of 5 mm through which the pediatric cystoscope can pass. We utilized a 1% mannitol solution for sinus irrigation. The hair follicles and necrotic tissues were eliminated. Then, the sinus was effectively cauterized using a monopolar probe. The inside of the sinus was cleaned with a brush
干预措施: Crystallized Phenol Applied (Procedure)
Limberg Flap Group (Group L) n:23
The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.
干预措施: Crystallized Phenol Applied (Procedure)
Modified Limberg Flap Group (Group ML) n:22
The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.
干预措施: Crystallized Phenol Applied (Procedure)
结局指标
主要结局
complications
时间窗: 30 days
Recurrence
pain score
时间窗: 24 hours
VAS score under 4,VAS score above 4
次要结局
- sinus volume measurement(24 hours)
研究者
Zeliha Alicikus
Assoc. prof. dr
Umraniye Education and Research Hospital