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.
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
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 group | Role | What they receive |
|---|---|---|
| Ligation and Hemorrhoidopexy | Experimental | 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. Receives: Procedure: Ligation and Hemorrhoidopexy |
| Ultrasound Guided Ligation of Hemorrhoidal Arteries | Active comparator | 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. 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.
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)
Operative time
The total operative time will be recorded. Measurement unit: minutes
Measured: Intraoperative period
Postoperative mobilization time
The postoperative mobilization time of the patient will be recorded. Measurement unit: hours
Measured: Maximum time frame 24 hours postoperatively
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Satisfaction level
Satisfaction level measured at a 0-10 scale
Measured: 1 year postoperatively
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.
- First posted2 Oct 2017
- Study start1 Oct 2017
- Primary completion15 Apr 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Perivoliotis Konstantinos, Larissa University Hospital
- Investigators
- Konstantinos Tepetes, Professor, Study director, Department of Surgery, University Hospital of Larissa
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 18294271Riss 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 21932016Schuurman 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 19175645Rivadeneira 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 21825884Ho 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 9448627Hosch 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 9556238Senagore 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 15622574Chung 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 15793648Lawes 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 15206964Pandini 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 16919112Chung 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 12072632Shanmugam 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 16252313Khoury 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 3899248Ratto 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 20389215Morinaga 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03298997
- Acronym / sponsor ID
- Hemorrhoids RCT
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Ligation, Ultrasound, Prospective, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligation and Hemorrhoidopexy | Experimental | Procedure: Ligation and HemorrhoidopexyThe 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. |
| Ultrasound Guided Ligation of Hemorrhoidal Arteries | Active comparator | Procedure: Ultrasound Guided Ligation of Hemorrhoidal ArteriesThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Μale or female
- Age: 18 to 80 years
- American Society of Anesthesiologists (ASA) score: I and II
- Grade I, II, and III hemorrhoids
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligation and HemorrhoidopexyIdentification 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. | Procedure or surgery | Ligation and Hemorrhoidopexy |
| Ultrasound Guided Ligation of Hemorrhoidal ArteriesUltrasound 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. | Procedure or surgery | Ultrasound Guided Ligation of Hemorrhoidal Arteries |
Primary outcome
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'
26 secondary outcomes
Operative time
Time frame: Intraoperative period
Postoperative mobilization time
Time frame: Maximum time frame 24 hours postoperatively
Onset of oral feeding
Time frame: Maximum time frame 24 hours postoperatively
Postoperative pain level at 12 hours
Time frame: 12 hours postoperatively
Hypotension
Time frame: Maximum time frame 24 hours postoperatively
Nausea
Time frame: Maximum time frame 24 hours postoperatively
Vomiting
Time frame: Maximum time frame 24 hours postoperatively
Headache
Time frame: Maximum time frame 24 hours postoperatively
Urinary retention
Time frame: Maximum time frame 24 hours postoperatively
Bleeding at the operative site
Time frame: Maximum time frame 24 hours postoperatively
Postoperative discharge time
Time frame: Maximum time frame 48 hours postoperatively
Postoperative pain level at 7 days
Time frame: 7 days postoperatively
Oedema at the operative site
Time frame: 7 days postoperatively
Hematoma at the operative site
Time frame: 7 days postoperatively
Infection at the operative site
Time frame: 7 days postoperatively
Stenosis at the operative site
Time frame: 7 days postoperatively
Postoperative return to work time
Time frame: Postoperative period up to 1 month
Pruritus
Time frame: 1 year postoperatively
Mucosal proptosis
Time frame: 1 year postoperatively
Perianal nodules
Time frame: 1 year postoperatively
Constipation
Time frame: 1 year postoperatively
Tenesmus
Time frame: 1 year postoperatively
Reoperation
Time frame: 1 year postoperatively
Disease recurrence rate
Time frame: 1 year postoperatively
Satisfaction level
Time frame: 1 year postoperatively
Difference in the quality of life of the patient
Time frame: Preoperatively, 1 month postoperatively and 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 18294271Faiz 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.
- Background: PubMed 21932016Riss 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.
- Background: PubMed 19175645Schuurman 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.
- Background: PubMed 21825884Rivadeneira 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.
- Background: PubMed 9448627Ho 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.
- Background: PubMed 9556238Hosch 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.
- Background: PubMed 15622574Senagore 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.
- Background: PubMed 15793648Chung 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.
- Background: PubMed 15206964Lawes 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.
- Background: PubMed 16919112Pandini 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.
- Background: PubMed 12072632Chung 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.
- Background: PubMed 16252313Shanmugam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Tepetes, Professor study director
Department of Surgery, University Hospital of Larissa
1 site in 1 country: see every site and its status.
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.