Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease

Completed

• Conditions: Hemorrhoids External Thrombosed
• Interventions: Procedure: Surgical Treatment; Procedure: Conservative treatment

• Registration Number: NCT06009133
• Lead Sponsor: Konya Meram State Hospital

Brief Summary

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.

Detailed Description

Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.

While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.

AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .

In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-14
• Status Verified: 2023-08
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
• Patients with the onset of the complaint before 96 hours

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Exclusion Criteria

Patients under the age of 18 and patients over the age of 70

• Mentally retarded patients
• Pregnant patients
• Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)

Those with a history of proctology surgery

• Patients with grade 3-4 internal hemorrhoids
• Patients using anticoagulant drugs
• Patients whose complaint has passed 96 hours after onset

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Treatment Group	Surgical Treatment	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.
Conservative Treatment Group	Conservative treatment	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.

Primary Outcome Measures

Name	Time	Method
Pain score with visual analog scale	12 hours	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence	6 months	It was recorded whether the patients had hemorrhoid recurrence at 6 months.
Satisfaction survey	6 months	The satisfaction level of the participants was scored on a visual analog scale six months after the treatment. The visual analog scale was between 0 and 10 mm. 0 was rated as not at all satisfied, and 10 was rated as very satisfied.; Satisfaction questionnaire was applied to the patients at 6 months.
Time to return to daily activities	15 days	The patients' return to daily activities were recorded.

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey