Hemorrhoids
Conditions
Keywords
Hemorrhoids
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.
Interventions
PROCEDUREHemorrhoidal 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.
PROCEDUREStapled 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.
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain POD1 | between 6:00 am and 8:00 am the day after surgery | Visual analogue scale (VAS). Additionally recording of the pain medication used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain 30d | 30 days after surgery | visual analogue scale |
| Pain 1y | 1 year after surgery | visual analogue scale |
| Pain 2y | 2 years after surgery | visual analogue scale |
| post operative surgical complications | within 30 post operative days | Number and severity according to the Dindo classification (Ann Surg 240:205) |
| Pain after 8h | 8 hours after surgery | Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used. |
| Continence 30d | 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. |
| Continence 1y | 1 year after surgery | Wexner score |
| Continence 2y | 2 years after surgery | Wexner score Additionally anorectal manometry (results will be compared with pre-operative data). |
| duration of medical leave | up to 3 months after surgery | data will be obtained from primary care physician |
Countries
Switzerland
Outcome results
None listed