Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids
NCT ID: NCT03298997
Last Updated: 2020-10-12
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-10-01
2020-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ligation and Hemorrhoidopexy
The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Introduction of a proctoscope. Identification of the hemorrhoidal nodules (3rd, 7th, 11th hour). Confirmation of the hemorrhoidal artery location, through palpation. Ligation of the hemorrhoidal nodules using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Placement of a fixative suture in the hemorrhoidal nodule and then performance of hemorrhoidopexy Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to pudendal nerve block. Using an atraumatic 25 Gauge (G) needle, a 20ml lidocaine solution (diluted with saline in a 1:1 rate) will be administered bilaterally, medially to the ischial tuberosity.
10 minutes before the operation, the patient will receive 1-2.5mg midazolam and 0.1-0.2 mg fentanyl.
Ligation and Hemorrhoidopexy
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 Ligation of Hemorrhoidal Arteries
The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Use of a proctoscope combined with a Doppler sensor. After the hemorrhoidal artery localization, Z ligations will be placed, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
The proper artery ligation will be confirmed by the absence of the Doppler signal.
In the presence of residual hemorrhoidal tissue hemorrhoidopexy will be performed, by applying a continuous suture.
Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to spinal anesthesia. Using an atraumatic 25 Gauge (G) needle, a levobupivacaine 5mg/ml and fentanyl 25mg solution, will be administered at the height of lumbar (L)2-L3 or L3-L4.
Ultrasound Guided Ligation of Hemorrhoidal Arteries
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.
Interventions
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Ligation and Hemorrhoidopexy
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 Ligation of Hemorrhoidal Arteries
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.
Eligibility Criteria
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Inclusion Criteria
* Age: 18 to 80 years
* American Society of Anesthesiologists (ASA) score: I and II
* Grade I, II, and III hemorrhoids
Exclusion Criteria
* Malignant perianal disorders
* Patient age ≥ 80 years
* ASA score ≥ ΙΙΙ
* Presence of inflammatory bowel disease
* History of a previous rectoanal operation
18 Years
80 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Larissa University Hospital
OTHER
Responsible Party
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Perivoliotis Konstantinos
Perivoliotis Konstantinos MD, MSc Principal Investigator
Principal Investigators
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Konstantinos Tepetes, Professor
Role: STUDY_DIRECTOR
Department of Surgery, University Hospital of Larissa
Locations
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Department of Surgery, University Hospital of Larissa
Larissa, Larissa, Greece
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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Hemorrhoids RCT
Identifier Type: -
Identifier Source: org_study_id
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