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HemorrhoidsNCT03298997

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

A study testing Ligation and Hemorrhoidopexy and Ultrasound Guided Ligation of Hemorrhoidal Arteries in people with Hemorrhoids, run by Larissa University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hemorrhoids
What is being tested?
Ligation and Hemorrhoidopexy and Ultrasound Guided Ligation of Hemorrhoidal Arteries
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
1 Oct 2017to 15 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Department of Surgery, University Hospital of Larissa

    Larissa, Larissa, 41110

Other trials in Greece

About this study

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

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.

Read the 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.

Conditions
Hemorrhoids
Being tested
Ligation and Hemorrhoidopexy, Ultrasound Guided Ligation of Hemorrhoidal Arteries
Keywords
Hemorrhoids, Ligation, Ultrasound, Prospective, Randomized Controlled Trial
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ligation and HemorrhoidopexyProcedure or surgery

    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 ArteriesProcedure or surgery

    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.

Study groups in NCT03298997
Study groupRoleWhat they receive
Ligation and HemorrhoidopexyExperimentalThe 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.
Receives: Procedure: Ligation and Hemorrhoidopexy
Ultrasound Guided Ligation of Hemorrhoidal ArteriesActive comparatorThe 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.
Receives: Procedure: Ultrasound Guided Ligation of Hemorrhoidal Arteries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms Remission Rate

    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'

    Measured: 1 month postoperatively

Secondary outcomes (26)
  1. Operative time

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

    Measured: Intraoperative period

  2. Postoperative mobilization time

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

    Measured: Maximum time frame 24 hours postoperatively

  3. Onset of oral feeding

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

    Measured: Maximum time frame 24 hours postoperatively

  4. Postoperative pain level at 12 hours

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

    Measured: 12 hours postoperatively

  5. Hypotension

    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'

    Measured: Maximum time frame 24 hours postoperatively

  6. Nausea

    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'

    Measured: Maximum time frame 24 hours postoperatively

  7. Vomiting

    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'

    Measured: Maximum time frame 24 hours postoperatively

  8. Headache

    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'

    Measured: Maximum time frame 24 hours postoperatively

  9. Urinary retention

    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'

    Measured: Maximum time frame 24 hours postoperatively

  10. Bleeding at the operative site

    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'

    Measured: Maximum time frame 24 hours postoperatively

  11. Postoperative discharge time

    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.

    Measured: Maximum time frame 48 hours postoperatively

  12. Postoperative pain level at 7 days

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

    Measured: 7 days postoperatively

  13. Oedema at the operative site

    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'

    Measured: 7 days postoperatively

  14. Hematoma at the operative site

    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'

    Measured: 7 days postoperatively

  15. Infection at the operative site

    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'

    Measured: 7 days postoperatively

  16. Stenosis at the operative site

    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'

    Measured: 7 days postoperatively

  17. Postoperative return to work time

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

    Measured: Postoperative period up to 1 month

  18. Pruritus

    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'

    Measured: 1 year postoperatively

  19. Mucosal proptosis

    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'

    Measured: 1 year postoperatively

  20. Perianal nodules

    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'

    Measured: 1 year postoperatively

  21. Constipation

    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'

    Measured: 1 year postoperatively

  22. Tenesmus

    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'

    Measured: 1 year postoperatively

  23. Reoperation

    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'

    Measured: 1 year postoperatively

  24. Disease recurrence rate

    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'

    Measured: 1 year postoperatively

  25. Satisfaction level

    Satisfaction level measured at a 0-10 scale

    Measured: 1 year postoperatively

  26. Difference in the quality of life of the patient

    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.

    Measured: Preoperatively, 1 month postoperatively and 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Oct 2017
  3. Primary completion15 Apr 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298997
Sponsor's protocol ID
Hemorrhoids RCT
Status last verified
Oct 2020
First submitted
22 Sep 2017
Last updated
12 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Faiz OD, Brown TJ, Colucci G, Grover M, Clark SK. Trends in colorectal day case surgery in NHS Trusts between 1998 and 2005. Colorectal Dis. 2008 Nov;10(9):935-42. doi: 10.1111/j.1463-1318.2008.01481.x. Epub 2008 Feb 21.

    PubMed 18294271
  • Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

    PubMed 21932016
  • Schuurman JP, Go PM, Bleys RL. Anatomical branches of the superior rectal artery in the distal rectum. Colorectal Dis. 2009 Nov;11(9):967-71. doi: 10.1111/j.1463-1318.2008.01729.x. Epub 2008 Oct 31.

    PubMed 19175645
  • Rivadeneira DE, Steele SR, Ternent C, Chalasani S, Buie WD, Rafferty JL; Standards Practice Task Force of The American Society of Colon and Rectal Surgeons. Practice parameters for the management of hemorrhoids (revised 2010). Dis Colon Rectum. 2011 Sep;54(9):1059-64. doi: 10.1097/DCR.0b013e318225513d. No abstract available.

    PubMed 21825884
  • Ho YH, Seow-Choen F, Tan M, Leong AF. Randomized controlled trial of open and closed haemorrhoidectomy. Br J Surg. 1997 Dec;84(12):1729-30.

    PubMed 9448627
  • Hosch SB, Knoefel WT, Pichlmeier U, Schulze V, Busch C, Gawad KA, Broelsch CE, Izbicki JR. Surgical treatment of piles: prospective, randomized study of Parks vs. Milligan-Morgan hemorrhoidectomy. Dis Colon Rectum. 1998 Feb;41(2):159-64. doi: 10.1007/BF02238242.

    PubMed 9556238
  • Senagore AJ, Singer M, Abcarian H, Fleshman J, Corman M, Wexner S, Nivatvongs S; Procedure for Prolapse and Hemmorrhoids (PPH) Multicenter Study Group. A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results. Dis Colon Rectum. 2004 Nov;47(11):1824-36. doi: 10.1007/s10350-004-0694-9.

    PubMed 15622574
  • Chung CC, Cheung HY, Chan ES, Kwok SY, Li MK. Stapled hemorrhoidopexy vs. Harmonic Scalpel hemorrhoidectomy: a randomized trial. Dis Colon Rectum. 2005 Jun;48(6):1213-9. doi: 10.1007/s10350-004-0918-z.

    PubMed 15793648
  • Lawes DA, Palazzo FF, Francis DL, Clifton MA. One year follow up of a randomized trial comparing Ligasure with open haemorrhoidectomy. Colorectal Dis. 2004 Jul;6(4):233-5. doi: 10.1111/j.1463-1318.2004.00608.x.

    PubMed 15206964
  • Pandini LC, Nahas SC, Nahas CS, Marques CF, Sobrado CW, Kiss DR. Surgical treatment of haemorrhoidal disease with CO2 laser and Milligan-Morgan cold scalpel technique. Colorectal Dis. 2006 Sep;8(7):592-5. doi: 10.1111/j.1463-1318.2006.01023.x.

    PubMed 16919112
  • Chung CC, Ha JP, Tai YP, Tsang WW, Li MK. Double-blind, randomized trial comparing Harmonic Scalpel hemorrhoidectomy, bipolar scissors hemorrhoidectomy, and scissors excision: ligation technique. Dis Colon Rectum. 2002 Jun;45(6):789-94. doi: 10.1007/s10350-004-6299-5.

    PubMed 12072632
  • Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Systematic review of randomized trials comparing rubber band ligation with excisional haemorrhoidectomy. Br J Surg. 2005 Dec;92(12):1481-7. doi: 10.1002/bjs.5185.

    PubMed 16252313
  • Khoury GA, Lake SP, Lewis MC, Lewis AA. A randomized trial to compare single with multiple phenol injection treatment for haemorrhoids. Br J Surg. 1985 Sep;72(9):741-2. doi: 10.1002/bjs.1800720924.

    PubMed 3899248
  • Ratto C, Donisi L, Parello A, Litta F, Doglietto GB. Evaluation of transanal hemorrhoidal dearterialization as a minimally invasive therapeutic approach to hemorrhoids. Dis Colon Rectum. 2010 May;53(5):803-11. doi: 10.1007/DCR.0b013e3181cdafa7.

    PubMed 20389215
  • Morinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995 Apr;90(4):610-3.

    PubMed 7717320

Questions about this trial

What is this clinical trial studying?

A study testing Ligation and Hemorrhoidopexy and Ultrasound Guided Ligation of Hemorrhoidal Arteries in people with Hemorrhoids, run by Larissa University Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms Remission Rate (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298997, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.

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