Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hemorrhoids	Procedure: Hemorrhoidal artery ligation with rectoanal repair; Procedure: Stapled hemorrhoidopexy	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	84 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Study Start Date :	July 2011
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pain [ Time Frame: between 6:00 am and 8:00 am the day after surgery ]

   Visual analogue scale (VAS).

   Additionally recording of the pain medication used.

Secondary Outcome Measures :

1. Pain [ Time Frame: 8 h after surgery ]

   Measuring post operative pain using the visual analogue scale (0 - 10).

   Additionally recording of the pain medication used.

2. Pain [ Time Frame: 30 days after surgery ]
   visual analogue scale
3. Pain [ Time Frame: 1 year after surgery ]
   visual analogue scale
4. Pain [ Time Frame: 2 years after surgery ]
   visual analogue scale
5. post operative surgical complications [ Time Frame: within 30 post operative days ]
   Number and severity according to the Dindo classification (Ann Surg 240:205)
6. duration of medical leave [ Time Frame: up to 3 months after surgery ]
   data will be obtained from primary care physician
7. Continence [ Time Frame: 30 days after surgery ]

   Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77).

   Score will be compared with pre-operative score.

8. Continence [ Time Frame: 1 year after surgery ]
   Wexner score
9. Continence [ Time Frame: 2 years after surgery ]

   Wexner score

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Website of the Department of Surgery (in German only) 

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
First Posted:	July 24, 2012
Last Update Posted:	July 24, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Lukas Marti, Cantonal Hospital of St. Gallen:

Hemorrhoids

Additional relevant MeSH terms:

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