Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2016 by Cantonal Hospital of St. Gallen

Sponsor:

Information provided by (Responsible Party):

Lukas Marti, Cantonal Hospital of St. Gallen

ClinicalTrials.gov Identifier:

NCT01647763

First received: July 18, 2012

Last updated: June 22, 2016

Last verified: June 2016

History of Changes

Purpose

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.

Condition	Intervention
Hemorrhoids	Procedure: Hemorrhoidal artery ligation with rectoanal repair Procedure: Stapled hemorrhoidopexy


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

Pain [ Time Frame: between 6:00 am and 8:00 am the day after surgery ] [ Designated as safety issue: Yes ]
Visual analogue scale (VAS).

Additionally recording of the pain medication used.

Secondary Outcome Measures:

Pain [ Time Frame: 8 h after surgery ] [ Designated as safety issue: Yes ]
Measuring post operative pain using the visual analogue scale (0 - 10).

Additionally recording of the pain medication used.
Pain [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
visual analogue scale
Pain [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
visual analogue scale
Pain [ Time Frame: 2 years after surgery ] [ Designated as safety issue: Yes ]
visual analogue scale
post operative surgical complications [ Time Frame: within 30 post operative days ] [ Designated as safety issue: Yes ]
Number and severity according to the Dindo classification (Ann Surg 240:205)
duration of medical leave [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
data will be obtained from primary care physician
Continence [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77).

Score will be compared with pre-operative score.
Continence [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
Wexner score
Continence [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]
Wexner score

Additionally anorectal manometry (results will be compared with pre-operative data).


Estimated Enrollment:	84
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HAL/RAR hemorrhoidal artery ligation with rectoanal repair	Procedure: Hemorrhoidal artery ligation with rectoanal repair 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. Other Names: HAL (hemorrhoidal artery ligation) RAR (rectoanal repair)
Active Comparator: Stapled hemorrhoidopexy procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler	Procedure: Stapled hemorrhoidopexy 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. Other Name: Longo procedure

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647763

Contacts


Contact: Lukas Marti, MD	+41 71 494 1339	lukas.marti@kssg.ch
Contact: Stephan Bischofberger, MD	+41 71 494 1111

Locations


Switzerland
Kantonsspital Rorschach	Recruiting
_Rorschach, Switzerland, 9400
Contact: Susanne Bock, MD +41 71 858 1111 susanne.bock@kssg.ch
Contact: Lukas Marti, MD lukas.marti@kssg.ch
Kantonsspital St. Gallen	Recruiting
St. Gallen, Switzerland, 9007
Contact: Lukas Marti, MD +41 71 494 1339 lukas.marti@kssg.ch
Principal Investigator: Lukas Marti, MD

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators


Principal Investigator:	Lukas Marti, MD	Cantonal Hospital St. Gallen, Department of Surgery

More Information

Additional Information:

Website of the Department of Surgery (in German only) This link exits the ClinicalTrials.gov site


Responsible Party:	Lukas Marti, Leitender Arzt (attending surgeon), Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT01647763 History of Changes
Other Study ID Numbers:	EKSG11/042
Study First Received:	July 18, 2012
Last Updated:	June 22, 2016
Health Authority:	Switzerland: Ethikkommission
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Cantonal Hospital of St. Gallen:


Hemorrhoids

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016

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