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

NCT03298997 | Completed DMC

• 1 other identifier: Hemorrhoids RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoids

Keywords

Hemorrhoids; Ligation; Ultrasound; Prospective; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (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'

  1 month postoperatively

Secondary Outcomes (26)

• Operative time

  Intraoperative period

• Postoperative mobilization time

  Maximum time frame 24 hours postoperatively

• Onset of oral feeding

  Maximum time frame 24 hours postoperatively

• Postoperative pain level at 12 hours

  12 hours postoperatively

• Hypotension

  Maximum time frame 24 hours postoperatively

Study Arms (2)

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.

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.

Procedure: Ultrasound Guided Ligation of Hemorrhoidal Arteries

Interventions

Ligation and Hemorrhoidopexy PROCEDURE

Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle). Prior to operation, the patients will be submitted to pudendal nerve block.

Ligation and Hemorrhoidopexy

Ultrasound Guided Ligation of Hemorrhoidal Arteries PROCEDURE

Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle). Prior to operation, the patients will be submitted to spinal anesthesia.

Ultrasound Guided Ligation of Hemorrhoidal Arteries

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Thessaly: collaborator

Study Sites (1)

Department of Surgery, University Hospital of Larissa

Larissa, Larissa, 41110, Greece

Location

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MeSH Terms

Conditions

Hemorrhoids

Interventions

Ligation

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Konstantinos Tepetes, Professor

  Department of Surgery, University Hospital of Larissa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, regarding the surgical technique applied. There will be no blinding at the level of the surgeon and the anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Perivoliotis Konstantinos MD, MSc Principal Investigator

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 2, 2017
• Study Start: October 1, 2017
• Primary Completion: April 15, 2020
• Study Completion: July 15, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)