Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Symptoms Remission Rate
研究概览
简要总结
The purpose of this study is to compare two techniques for treating hemorrhoids, the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoids.
详细描述
Surgical operations for the treatment of perianal diseases are a major part of all elective surgical cases. The reduction in the hospitalization time of patients undergoing surgical procedures for benign perianal diseases is to the benefit of both the patient and healthcare provider. The importance of 'one day' surgical operations lies in the fact that the patient returns directly to his social and working environment, while the number of occupied hospital beds and the total hospitalization costs are reduced. A typical example is the goal set by National Health Service (NHS), where the 75% of the scheduled operations should consist of 'one day' operations. In order to achieve this goal, several obstacles should be dealt with, including the implementation of more efficient and safe surgical techniques. Therefore, this would be associated with a decrease in the operation time, early recovery and faster hospital discharge.
Hemorrhoids is one of the most common benign perianal diseases. According to a recent prospective study of 976 patients, 38.93% of them suffered from hemorrhoids, with 8.16% and 0.53% being Grade III and IV, according to Goligher classification, respectively. The percentage of the symptomatic patients was, also, significant (44.74%). Symptomatic hemorrhoids, include bleeding, pruritus, pain, poor hygiene and the presence of palpable hemorrhoid nodules.
As far as the blood supply of the rectum and the broader anatomic region is concerned, it is provided by the superior, middle and inferior hemorrhoidal arteries. The superior hemorrhoidal artery is a branch of the inferior mesenteric artery and is carried behind the rectum, where it provides branches up to the internal sphincter muscle. The right and left middle hemorrhoidal artery originate from the respective internal iliac artery and their branches are cross-linked with the respective branches deriving from the superior hemorrhoidal artery. Finally, inferior hemorrhoidal arteries derive from the respective internal pudendal arteries. Correspondingly, hemorrhoidal venous plexus consists of the middle and inferior hemorrhoidal veins, which through the internal iliac veins drain into the inferior cava vein. Hemorrhoidal tissue constitutes a continence mechanism of the upper rectum and consists of vascular tissue, connective tissue and smooth muscle fibers, within the rectal canal. Through the approximation of the hemorrhoidal tissue, closure of the anal canal and protection of the sphincter mechanism is achieved. Since modern pathogenesis theories of hemorrhoidal disease attribute to the increased arterial flow in the hemorrhoidal plexus the generating cause of this disease, recent anatomical studies mapped the vascular network, indicating that the arteries are not confined to the anatomical regions described in the literature.
According to recent guidelines, the modification of dietary intake, through the increase of fluid and fiber intake, consists the first line treatment of symptomatic hemorrhoidal disease. However, in Grade III-IV hemorrhoidal disease or in Grade II, where conservative therapy failed, surgical intervention is required. Surgeon has plenty of techniques at his disposal, in order to treat hemorrhoids. Examples of these techniques are operations, such as hemorrhoidectomy (open, closed, Milligan-Morgan, Parks, using staplers, using energy sources, e.g. Harmonic, Ligasure, Laser, bipolar forceps), elastic rings ligation, sclerotherapy and Hemorrhoidal Arteries Ligation (ΗΑL) or Transanal Hemorrhoidal Dearterialization (THD).
Ligation of hemorrhoidal arteries using a Doppler apparatus, is a minimally invasive technique that was first applied by Morinaga et al. in 1995 and has as principle the elective ligation of the arteries that supply the hemorrhoidal plexus. In a recent meta-analysis, the superiority of HAL in areas such as, postoperative bleeding, emergency reoperation, operative duration, length of hospital stay and postoperative pain, was shown. A major drawback of this technique, however, remains the high rate of recurrence, which ranges from 11.1% to 59.3%, for Grade IV hemorrhoids.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, regarding the surgical technique applied. There will be no blinding at the level of the surgeon and the anesthesiologist.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Μale or female
- •Age: 18 to 80 years
- •American Society of Anesthesiologists (ASA) score: I and II
- •Grade I, II, and III hemorrhoids
排除标准
- •Acute perianal diseases, such as perianal abscesses, complicated hemorrhoids (e.g., thrombosis) and acute anal fissure
- •Malignant perianal disorders
- •Patient age ≥ 80 years
- •ASA score ≥ ΙΙΙ
- •Presence of inflammatory bowel disease
- •History of a previous rectoanal operation
- •Presence of a clinically significant cardiovascular, respiratory, renal, hepatic or metabolic disorder. Furthermore, diseases, such as obesity, psychiatric disorders or gastrointestinal disorders constitute exclusion criteria
结局指标
主要结局
Symptoms Remission Rate
时间窗: 1 month postoperatively
The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, within one month postoperatively, between the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoidal disease. If the symptoms are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'
次要结局
- Operative time(Intraoperative period)
- Postoperative mobilization time(Maximum time frame 24 hours postoperatively)
- Onset of oral feeding(Maximum time frame 24 hours postoperatively)
- Hypotension(Maximum time frame 24 hours postoperatively)
- Nausea(Maximum time frame 24 hours postoperatively)
- Vomiting(Maximum time frame 24 hours postoperatively)
- Headache(Maximum time frame 24 hours postoperatively)
- Stenosis at the operative site(7 days postoperatively)
- Pruritus(1 year postoperatively)
- Reoperation(1 year postoperatively)
- Postoperative pain level at 12 hours(12 hours postoperatively)
- Bleeding at the operative site(Maximum time frame 24 hours postoperatively)
- Postoperative discharge time(Maximum time frame 48 hours postoperatively)
- Oedema at the operative site(7 days postoperatively)
- Hematoma at the operative site(7 days postoperatively)
- Infection at the operative site(7 days postoperatively)
- Mucosal proptosis(1 year postoperatively)
- Constipation(1 year postoperatively)
- Urinary retention(Maximum time frame 24 hours postoperatively)
- Postoperative return to work time(Postoperative period up to 1 month)
- Perianal nodules(1 year postoperatively)
- Tenesmus(1 year postoperatively)
- Satisfaction level(1 year postoperatively)
- Postoperative pain level at 7 days(7 days postoperatively)
- Difference in the quality of life of the patient(Preoperatively, 1 month postoperatively and 1 year postoperatively)
- Disease recurrence rate(1 year postoperatively)
研究者
Perivoliotis Konstantinos
Perivoliotis Konstantinos MD, MSc Principal Investigator
Larissa University Hospital
