Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

NCT01647763 | Unknown

• 1 other identifier: EKSG11/042
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain. Hypothesis and aim: The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.

Conditions

Hemorrhoids

Keywords

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Pain POD1

  Visual analogue scale (VAS). Additionally recording of the pain medication used.

  between 6:00 am and 8:00 am the day after surgery

Secondary Outcomes (9)

• Pain after 8h

  8 hours after surgery

• Pain 30d

  30 days after surgery

• Pain 1y

  1 year after surgery

• Pain 2y

  2 years after surgery

• post operative surgical complications

  within 30 post operative days

Study Arms (2)

HAL/RAR

EXPERIMENTAL

hemorrhoidal artery ligation with rectoanal repair

Procedure: Hemorrhoidal artery ligation with rectoanal repair

Stapled hemorrhoidopexy

ACTIVE COMPARATOR

procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler

Procedure: Stapled hemorrhoidopexy

Interventions

Hemorrhoidal artery ligation with rectoanal repair PROCEDURE

Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures. In the area with the 3 largest knots a purse string suture will be placed.

Also known as: HAL (hemorrhoidal artery ligation), RAR (rectoanal repair)

HAL/RAR

Stapled hemorrhoidopexy PROCEDURE

A purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured.

Also known as: Longo procedure

Stapled hemorrhoidopexy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemorrhoids grade 3
• no active anti-coagulation treatment
• no hemorrhoidal recurrence
• no previous surgery on rectum or anus
• no previous local radiotherapy
• no mental incapacities, good study compliance can be expected
• no severe incontinence (Wexner score \> 12)
• no severe comorbidities
• no inflammatory anal diseases (abscesses, fistulas)
• informed consent

You may not qualify if:

• patient wish
• inoperability with the assigned intervention, switching to other treatment method

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (2)

Kantonsspital Rorschach

_Rorschach, 9400, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Links

• Website of the Department of Surgery (in German only)

MeSH Terms

Conditions

Hemorrhoids

Interventions

Retinoic Acid Receptor alpha

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Receptors, Retinoic Acid; Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Study Officials

• Lukas Marti, MD

  Cantonal Hospital St. Gallen, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leitender Arzt (attending surgeon)

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 24, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)