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

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298997
• Other study ID #: Hemorrhoids RCT
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 15, 2020

Study information

• Verified date: October 2020
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ?ale 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 = ???

• 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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Greece	Department of Surgery, University Hospital of Larissa	Lárisa	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (30)

Aigner F, Kronberger I, Oberwalder M, Loizides A, Ulmer H, Gruber L, Pratschke J, Peer S, Gruber H. Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial. Colorectal Dis. 2016 Jul;18(7):710-6. doi: 10.1111/codi.13280. — View Citation

Alkhaldi HM, Salaita WM, Shabaneh MA, Al-Horut MI, Aldabbas RM, Uraiqat AA. Postoperative Outcome Comparison Between Pudendal Nerve Block and Caudal Block After Lateral Open Internal Sphincterotomy. Med Arch. 2015 Jun;69(3):187-9. doi: 10.5455/medarh.2015.69.187-189. Epub 2015 Jun 10. — View Citation

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. — View Citation

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. — View Citation

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Giordano P, Overton J, Madeddu F, Zaman S, Gravante G. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum. 2009 Sep;52(9):1665-71. doi: 10.1007/DCR.0b013e3181af50f4. Review. — View Citation

Gupta PJ, Kalaskar S, Taori S, Heda PS. Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids. Tech Coloproctol. 2011 Dec;15(4):439-44. doi: 10.1007/s10151-011-0780-7. Epub 2011 Oct 28. — View Citation

Gupta PJ, Kalaskar S. Ligation and mucopexy for prolapsing hemorrhoids--a ten year experience. Ann Surg Innov Res. 2008 Nov 28;2:5. doi: 10.1186/1750-1164-2-5. — View Citation

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. — View Citation

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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. — View Citation

Huang HX, Yao YB, Tang Y. Application of 'tying, binding and fixing operation' in surgical treatment of severe mixed hemorrhoids. Exp Ther Med. 2016 Aug;12(2):1022-1028. Epub 2016 May 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. — View Citation

Perivoliotis K, Spyridakis M, Zintzaras E, Arnaoutoglou E, Pramateftakis MG, Tepetes K. An enhanced outpatient modality for the treatment of hemorrhoidal disease: preliminary results. G Chir. 2019 Mar-Apr;40(2):153-157. — View Citation

Perivoliotis K, Spyridakis M, Zintzaras E, Arnaoutoglou E, Pramateftakis MG, Tepetes K. Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hemorrhoidal disease: a non-inferiority randomized — View Citation

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. — View Citation

Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Dis Colon Rectum. 2005 Feb;48(2):400. Dis Colon Rectum. 2005 May;48(5):1099. — View Citation

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. Review. — View Citation

Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30. Review. — View Citation

Spyridakis M, Christodoulidis G, Symeonidis D, Dimas D, Diamantis A, Polychronopoulou E, Tepetes K. Outcomes of Doppler-guided hemorrhoid artery ligation: analysis of 90 consecutive patients. Tech Coloproctol. 2011 Oct;15 Suppl 1:S21-4. doi: 10.1007/s10151-011-0727-z. — View Citation

Tepetes K, Symeonidis D, Christodoulidis G, Spyridakis M, Hatzitheofilou K. Pudendal nerve block versus local anesthesia for harmonic scalpel hemorrhoidectomy: a prospective randomized study. Tech Coloproctol. 2010 Nov;14 Suppl 1:S1-3. doi: 10.1007/s10151-010-0614-z. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'	1 month postoperatively
Secondary	Operative time	The total operative time will be recorded. Measurement unit: minutes	Intraoperative period
Secondary	Postoperative mobilization time	The postoperative mobilization time of the patient will be recorded. Measurement unit: hours	Maximum time frame 24 hours postoperatively
Secondary	Onset of oral feeding	The time that the patient started oral feeding will be recorded. Measurement unit: hours	Maximum time frame 24 hours postoperatively
Secondary	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.	12 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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'	Maximum time frame 24 hours postoperatively
Secondary	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.	Maximum time frame 48 hours postoperatively
Secondary	Postoperative pain level at 7 days	Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale.	7 days postoperatively
Secondary	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'	7 days postoperatively
Secondary	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'	7 days postoperatively
Secondary	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'	7 days postoperatively
Secondary	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'	7 days postoperatively
Secondary	Postoperative return to work time	The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days	Postoperative period up to 1 month
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	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'	1 year postoperatively
Secondary	Satisfaction level	Satisfaction level measured at a 0-10 scale	1 year postoperatively
Secondary	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.	Preoperatively, 1 month postoperatively and 1 year postoperatively