Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease
Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
Sponsor study identifier
observational
132
1 country
1
Study Start
July 1, 2022
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
March 14, 2023
Actual (reported)Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 14, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2022
Actual (reported)December 31, 2022
Actual (reported)March 14, 2023
Actual (reported)August 17, 2023
Actual (reported)August 24, 2023
Actual (reported)Pain score with visual analog scale
The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.
12 hours
Time to return to daily activities
15 days
Recurrence
6 months
Satisfaction survey
6 months
Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month. Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.
While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.
Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month. Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.
The population of the study consisted of patients who applied to the general surgery outpatient clinic due to acute external thrombosed hemorrhoids disease. Patients who fully met the inclusion criteria and did not meet the exclusion criteria constituted the sample group.
Konya Training and Research Hospital
Konya, 42090, Turkey (Türkiye)
Hasan Yaldız, MD
Konya City Hospital
132 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2023
First Posted
August 24, 2023
Study Start
July 1, 2022
Actual (reported)The Effect of Manual Lymph Drainage in Fibromyalgia Patients
While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.
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Primary Completion
December 31, 2022
Actual (reported)Study Completion
March 14, 2023
Actual (reported)Last Updated
August 28, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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