Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Despite the comparative advantages of this minimally invasive technique, the high cost of the
      necessary equipment and the respective consumables, is a barrier to its broad application.
      Gupta et al. in a prospective randomized study, compared Doppler-Guided HAL (DG-HAL) to
      hemorrhoid artery ligation and hemorrhoidopexy. Ligation was performed on the hemorrhoid
      nodule at the 3rd, 7th and 11th hours, followed by continuous hemorrhoidal nodule ligation
      and hemorrhoidopexy. The DG-HAL group had a significantly longer operative time (31 min vs 9
      min) and post-operative pain (4.4 vs 2.2), without any differences in complication or
      recurrence rates. Similarly, Huang et al., reported a respective ligation technique, where,
      through the use of the index finger, the artery was palpated, followed by repeating
      compression and ligation cycles, in order to fix the affected hemorrhoids above the dental
      line. In this group, operative time was longer when compared to the DG-HAL group (35.57 vs.
      12.73). There was no difference in terms of postoperative improvement of symptoms and
      hospitalization duration. In the experimental group, however, the cost of hospitalization and
      the relapse rate was significantly lower. Finally, Aigner et al., in a recent randomized
      study, investigated the efficacy of hemorrhoidopexy for Grade III hemorrhoids. They concluded
      that the techniques of hemorrhoidopexy are effective and the addition of DG-HAL does not
      affect the results.

      Given these facts, the present trial was designed, in order to compare the two techniques for
      hemorrhoidal disease treatment, the ligation and hemorrhoidopexy technique and the
      conventional ligation of hemorrhoid arteries using ultrasound.
    

Intervention name(s): Ligation and Hemorrhoidopexy; Ultrasound Guided Ligation of Hemorrhoidal Arteries
Intervention type(s): Procedure; Procedure
Intervention description(s): Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Prior to operation, the patients will be submitted to pudendal nerve block.; Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Prior to operation, the patients will be submitted to spinal anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemorrhoids; Ligation; Ultrasound; Prospective; Randomized Controlled Trial