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OpenTrials
Completed

NCT Number: NCT03298997

Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, University Hospital of Larissa

Larissa, 41110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Μale or female
  • Age: 18 to 80 years
  • American Society of Anesthesiologists (ASA) score: I and II
  • Grade I, II, and III hemorrhoids

Exclusion criteria

  • 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

Treatment and study plan

Ligation and Hemorrhoidopexy

Procedure

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

Procedure

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.

Primary outcomes

  1. Symptoms Remission Rate

    Time frame: 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'

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative period

    The total operative time will be recorded. Measurement unit: minutes

  2. Postoperative mobilization time

    Time frame: Maximum time frame 24 hours postoperatively

    The postoperative mobilization time of the patient will be recorded. Measurement unit: hours

  3. Onset of oral feeding

    Time frame: Maximum time frame 24 hours postoperatively

    The time that the patient started oral feeding will be recorded. Measurement unit: hours

  4. Postoperative pain level at 12 hours

    Time frame: 12 hours postoperatively

    Postoperative pain level at 12 hours after surgery, quantified with the use of the Visual analogue scale (VAS) scale.

  5. Hypotension

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative hypotension. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  6. Nausea

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative nausea. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  7. Vomiting

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative vomiting. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  8. Headache

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative headache. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  9. Urinary retention

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative urinary retention. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  10. Bleeding at the operative site

    Time frame: Maximum time frame 24 hours postoperatively

    Occurrence of postoperative bleeding at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  11. Postoperative discharge time

    Time frame: Maximum time frame 48 hours postoperatively

    Postoperative time that the patient can be safely discharged. Measurement unit: hours.

    The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfill the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding.

  12. Postoperative pain level at 7 days

    Time frame: 7 days postoperatively

    Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale.

  13. Oedema at the operative site

    Time frame: 7 days postoperatively

    Occurrence of postoperative oedema at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  14. Hematoma at the operative site

    Time frame: 7 days postoperatively

    Occurrence of postoperative hematoma at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  15. Infection at the operative site

    Time frame: 7 days postoperatively

    Occurrence of postoperative infection at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  16. Stenosis at the operative site

    Time frame: 7 days postoperatively

    Occurrence of postoperative stenosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  17. Postoperative return to work time

    Time frame: Postoperative period up to 1 month

    The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days

  18. Pruritus

    Time frame: 1 year postoperatively

    Occurrence of postoperative pruritus at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  19. Mucosal proptosis

    Time frame: 1 year postoperatively

    Occurrence of postoperative mucosal proptosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  20. Perianal nodules

    Time frame: 1 year postoperatively

    Occurrence of postoperative perianal nodules. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  21. Constipation

    Time frame: 1 year postoperatively

    Occurrence of postoperative constipation. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  22. Tenesmus

    Time frame: 1 year postoperatively

    Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  23. Reoperation

    Time frame: 1 year postoperatively

    Occurrence of reoperation. If the patient is reoperated, then it will be defined as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'

  24. Disease recurrence rate

    Time frame: 1 year postoperatively

    Disease recurrence rate If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  25. Satisfaction level

    Time frame: 1 year postoperatively

    Satisfaction level measured at a 0-10 scale

  26. Difference in the quality of life of the patient

    Time frame: Preoperatively, 1 month postoperatively and 1 year postoperatively

    Difference in the quality of life of the patient, at 1 month and 1 year postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire, weighted for the Greek population.

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Collaborators

  • University of Thessaly

Registry information

Official study title

Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2017
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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