Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
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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 |
- 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.
- 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 2017 |
| Estimated Primary Completion Date: | December 2015 (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:
|
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01647763
| Contact: Lukas Marti, MD | +41 71 494 1339 | lukas.marti@kssg.ch | |
| Contact: Stephan Bischofberger, MD | +41 71 494 1111 |
| 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 | |
| Principal Investigator: | Lukas Marti, MD | Cantonal Hospital St. Gallen, Department of Surgery |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lukas Marti, Oberarzt mbF (attending physician), 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: | January 28, 2015 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Cantonal Hospital of St. Gallen:
|
Hemorrhoids |
ClinicalTrials.gov processed this record on February 27, 2015