An interventional study of Hemorrhoidal artery ligation with rectoanal repair and Stapled hemorrhoidopexy in Hemorrhoids, sponsored by Cantonal Hospital of St. Gallen. Active, not recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Cantonal Hospital of St. Gallen · Not applicable, Interventional, and Treatment
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's planned enrollment of 84 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
hemorrhoidal artery ligation with rectoanal repair
Procedure: Hemorrhoidal artery ligation with rectoanal repair
procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler
Procedure: Stapled hemorrhoidopexy
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)
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
Pain POD1
Visual analogue scale (VAS). Additionally recording of the pain medication used.
Time frame: between 6:00 am and 8:00 am the day after surgery
Pain after 8h
Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used.
Time frame: 8 hours after surgery
Pain 30d
visual analogue scale
Time frame: 30 days after surgery
Pain 1y
visual analogue scale
Time frame: 1 year after surgery
Pain 2y
visual analogue scale
Time frame: 2 years after surgery
post operative surgical complications
Number and severity according to the Dindo classification (Ann Surg 240:205)
Time frame: within 30 post operative days
duration of medical leave
data will be obtained from primary care physician
Time frame: up to 3 months after surgery
Continence 30d
Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77). Score will be compared with pre-operative score.
Time frame: 30 days after surgery
Continence 1y
Wexner score
Time frame: 1 year after surgery
Continence 2y
Wexner score Additionally anorectal manometry (results will be compared with pre-operative data).
Time frame: 2 years after surgery
Plan to share: No
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Cantonal Hospital of St. Gallen