HAL-RAR Technique for Treating Hemorrhoids

NCT04778124 | Completed

• 1 other identifier: 2042/4-3-2020
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

A wide variety of methods has been proposed for treating hemorrhoidal disease with excisional hemorrhoidectomy remaining the gold standard. The aim of this trial is to assess the safety and effectiveness of the HAL-RAR technique in treating hemorrhoidal disease. Arterial ligation was performed by using the highest doppler signal to locate the site of the hemorrhoidal artery in combination with RAR in order to reposition redundant rectal mucosa/submucosa that prolapses to its original anatomical location, leading to resolution of symptoms. This is a retrospective study from January 2010 to November 2019 of patients who underwent HAL-RAR for hemorrhoidal disease. Demographics, degree of disease, length of hospital stay, postoperative pain, complications (urinary retention, dyschezia, bleeding, necrosis of a hemorrhoid, anal discomfort, sensation of fullness) and recurrence were recorded. Patients were followed-up at postoperative day 1 and 8, and at 1, 6 and 12 months. The main outcome of the study was recurrence. Secondary outcomes included postoperative complications, postoperative pain and patient-assessed resolution of symptoms.

Conditions

Hemorrhoidal Disease

Keywords

hemorrhoidal disease; treatment; HAL; RAR; mucopexy

Outcome Measures

Primary Outcomes (3)

• Recurrence

  Recurrence was evaluated after physical examination and defined as a relapse of symptoms such as bleeding or prolapse often daily requiring manual reduction.

  Postoperatively at 1 month

• Recurrence

  Recurrence was evaluated after physical examination and defined as a relapse of symptoms such as bleeding or prolapse often daily requiring manual reduction.

  Postoperatively at 6 months

• Recurrence

  Recurrence was evaluated after physical examination and defined as a relapse of symptoms such as bleeding or prolapse often daily requiring manual reduction.

  Postoperatively at 12 months

Secondary Outcomes (11)

• Postoperative complications

  Postoperative day 1

• Postoperative complications

  Postoperative day 8

• Postoperative complications

  Postoperatively at 1 month

• Postoperative pain

  Postoperative day 1

• Postoperative pain

  Postoperative day 8

Study Arms (1)

Patients with hemorrhoidal disease undergoing HAL-RAR

OTHER

This is a single-arm trial, in which all patients with grade II hemorrhoidal disease resistant to conservative treatment, grade III and IV hemorrhoidal disease underwent HAL RAR surgery.

Procedure: Hemorrhoidal Arterial Ligation (HAL) and Recto Anal Repair (RAR); Procedure: Excision of thrombosed hemorrhoid / Hemorrhoidectomy /

Interventions

Hemorrhoidal Arterial Ligation (HAL) and Recto Anal Repair (RAR) PROCEDURE

All patients underwent hemorrhoidal artery ligation on multiple sites according to pulsations detected by the doppler transducer and mucopexy (RAR) at the sites of prolapse.

Patients with hemorrhoidal disease undergoing HAL-RAR

Excision of thrombosed hemorrhoid / Hemorrhoidectomy / PROCEDURE

One patient with mucosal necrosis of the hemorrhoidal cushion postoperatively underwent hemorrhoidectomy with excision of necrotic tissues.Furthermore, 2 patients who presented with hemorrhoidal thrombosis postoperatively underwent emergency surgery with supplementary excision of the thrombosed hemorrhoid. In addition, 9 patients who experienced recurrence of hemorrhoidal disease after undergoing HAL-RAR surgery, were treated with hemorrhoidectomy according to the Milligan-Morgan procedure.

Patients with hemorrhoidal disease undergoing HAL-RAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with
• grade II hemorrhoidal disease, resistant to conservative treatment
• grade III hemorrhoidal disease,
• grade IV hemorhoidal disease,
• that underwent the HAL-RAR technique.

You may not qualify if:

• pregnancy
• coagulation disorders
• patients with major comorbidities (American Society of Anesthesiologists \[ASA\] ≥3),
• psychiatric conditions preventing collaboration and follow-up
• other concomitant anorectal disease (rectal prolapse, anal fissure, anal stenosis, perianal fistula or abscess, fecal incontinence)
• previous pelvic radiotherapy
• declined consent

Sponsors & Collaborators

• Amalia Fleming General Hospital: lead
• Sismanoglio - Amalia Fleming General Hospital: collaborator

Related Publications (7)

• 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.

  PMID: 7717320 BACKGROUND

• Ratto C, Campenni P, Papeo F, Donisi L, Litta F, Parello A. Transanal hemorrhoidal dearterialization (THD) for hemorrhoidal disease: a single-center study on 1000 consecutive cases and a review of the literature. Tech Coloproctol. 2017 Dec;21(12):953-962. doi: 10.1007/s10151-017-1726-5. Epub 2017 Nov 24.

  PMID: 29170839 BACKGROUND

• Popov V, Yonkov A, Arabadzhieva E, Zhivkov E, Bonev S, Bulanov D, Tasev V, Korukov G, Simonova L, Kandilarov N, Taseva A, Dimitrova V. Doppler-guided transanal hemorrhoidal dearterilization versus conventional hemorrhoidectomy for treatment of hemorrhoids - early and long-term postoperative results. BMC Surg. 2019 Jan 10;19(1):4. doi: 10.1186/s12893-019-0469-9.

  PMID: 30630463 BACKGROUND

• Aigner F, Gruber H, Conrad F, Eder J, Wedel T, Zelger B, Engelhardt V, Lametschwandtner A, Wienert V, Bohler U, Margreiter R, Fritsch H. Revised morphology and hemodynamics of the anorectal vascular plexus: impact on the course of hemorrhoidal disease. Int J Colorectal Dis. 2009 Jan;24(1):105-13. doi: 10.1007/s00384-008-0572-3. Epub 2008 Sep 3.

  PMID: 18766355 BACKGROUND

• Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020 Feb;24(2):145-164. doi: 10.1007/s10151-020-02149-1. Epub 2020 Jan 28.

  PMID: 31993837 BACKGROUND

• Emile SH, Elfeki H, Sakr A, Shalaby M. Transanal hemorrhoidal dearterialization (THD) versus stapled hemorrhoidopexy (SH) in treatment of internal hemorrhoids: a systematic review and meta-analysis of randomized clinical trials. Int J Colorectal Dis. 2019 Jan;34(1):1-11. doi: 10.1007/s00384-018-3187-3. Epub 2018 Nov 12.

  PMID: 30421308 BACKGROUND

• Karkalemis K, Chalkias PL, Kasouli A, Chatzaki E, Papanikolaou S, Dedemadi G. Safety and effectiveness of hemorrhoidal artery ligation using the HAL-RAR technique for hemorrhoidal disease. Langenbecks Arch Surg. 2021 Nov;406(7):2489-2495. doi: 10.1007/s00423-021-02190-0. Epub 2021 May 6.

  PMID: 33959805 DERIVED

MeSH Terms

Interventions

Hemorrhoidectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Georgia Dedemadi, MD, PhD

  Amalia Fleming Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FACS

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: January 1, 2010
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share