Clinical trial NCT06009133: Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease
Official title: Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids External Thrombosed
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Pain score with visual analog scale
timeFrame: 12 hours
Secondary outcomes:
measure: Time to return to daily activities
timeFrame: 15 days
measure: Recurrence
timeFrame: 6 months
measure: Satisfaction survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
affiliation: Konya City Hospital
name: Hasan Yaldız, MD
role: PRINCIPAL_INVESTIGATOR
References: