Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease

NCT06009133 | Completed

• 1 other identifier: Konya HH Group
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids External Thrombosed

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Time to return to daily activities

  15 days

• Recurrence

  6 months

• Satisfaction survey

  6 months

Study Arms (2)

Conservative Treatment 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.

Procedure: Conservative treatment

Surgical Treatment Group

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.

Procedure: Surgical Treatment

Interventions

Conservative treatment PROCEDURE

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.

Conservative Treatment Group

Surgical Treatment PROCEDURE

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.

Surgical Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Conservative Treatment; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hasan Yaldız, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 24, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 14, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

TU (1)