Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAL/RAR | Experimental | hemorrhoidal artery ligation with rectoanal repair |
|
| Stapled hemorrhoidopexy | Active Comparator | procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemorrhoidal artery ligation with rectoanal repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain POD1 | Visual analogue scale (VAS). Additionally recording of the pain medication used. | between 6:00 am and 8:00 am the day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain after 8h | Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used. | 8 hours after surgery |
| Pain 30d | visual analogue scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lukas Marti, MD | Cantonal Hospital St. Gallen, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Rorschach | _Rorschach | 9400 | Switzerland | |||
| Kantonsspital St. Gallen |
Not provided
| Label | URL |
|---|---|
| Website of the Department of Surgery (in German only) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072482 | Retinoic Acid Receptor alpha |
| ID | Term |
|---|---|
| D018168 | Receptors, Retinoic Acid |
| D018160 | Receptors, Cytoplasmic and Nuclear |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stapled hemorrhoidopexy | Procedure | 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. |
|
|
| 30 days after surgery |
| Pain 1y | visual analogue scale | 1 year after surgery |
| Pain 2y | visual analogue scale | 2 years after surgery |
| post operative surgical complications | Number and severity according to the Dindo classification (Ann Surg 240:205) | within 30 post operative days |
| duration of medical leave | data will be obtained from primary care physician | 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. | 30 days after surgery |
| Continence 1y | Wexner score | 1 year after surgery |
| Continence 2y | Wexner score Additionally anorectal manometry (results will be compared with pre-operative data). | 2 years after surgery |
| Sankt Gallen |
| 9007 |
| Switzerland |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014157 | Transcription Factors |