Postoperative Pain and Tenesmus After Doppler-Guided Hemorrhoidal Artery Ligation With or Without Mucopexy

NCT07710053 | Not Yet Recruiting

• 1 other identifier: 25-MOBAEK-080
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hemorrhoidal disease is one of the most common anorectal disorders affecting adults worldwide. Doppler-guided hemorrhoidal artery ligation (HAL) is a minimally invasive surgical technique that has gained popularity because of its lower postoperative pain and faster recovery compared with conventional hemorrhoidectomy. In selected patients, HAL may be combined with mucopexy to address prolapsing hemorrhoidal tissue. The aim of this prospective study is to compare postoperative pain and tenesmus between patients undergoing Doppler-guided hemorrhoidal artery ligation alone and those undergoing Doppler-guided hemorrhoidal artery ligation combined with mucopexy. Patients diagnosed with hemorrhoidal disease and scheduled for surgical treatment at the General Surgery Department of Tokat Gaziosmanpaşa University Hospital will be enrolled after obtaining ethics committee approval and informed consent. Eligible participants will be adults aged 18 years and older without any concomitant anal canal disease. Participants will be allocated into two groups according to the surgical technique performed: (1) Doppler-guided hemorrhoidal artery ligation alone and (2) Doppler-guided hemorrhoidal artery ligation combined with mucopexy. Postoperative pain will be assessed using a pain scale at the 8th postoperative hour and at the 1st postoperative month. Tenesmus symptoms will be evaluated and recorded at the 2nd postoperative month. The primary outcomes will be postoperative pain scores and the presence of tenesmus. Comparative statistical analyses will be performed between the two groups.

Conditions

Postoperative Pain

Keywords

Hemorrhoids; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (VAS)

  Assessment of pain severity using the Visual Analog Scale (VAS) at the 8th postoperative hour.

  Postoperative Hour 8

Secondary Outcomes (1)

• Postoperative Pain Score

  1 month after surgery

Study Arms (2)

HAL + Mucopexy

EXPERIMENTAL

Participants will undergo Doppler-guided hemorrhoidal artery ligation combined with mucopexy for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated, followed by mucopexy to reposition prolapsing hemorrhoidal tissue.

Procedure: HAL + Mucopexy

HAL Alone

ACTIVE COMPARATOR

Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy.

Procedure: HAL Alone

Interventions

HAL + Mucopexy PROCEDURE

Doppler-guided hemorrhoidal artery ligation will be performed using a Doppler-equipped proctoscope to identify and ligate hemorrhoidal arteries. Following arterial ligation, mucopexy will be performed to lift and secure the prolapsing hemorrhoidal mucosa.

HAL + Mucopexy

HAL Alone PROCEDURE

Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy.

HAL Alone

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Diagnosis of hemorrhoidal disease requiring surgical treatment
• Ability to provide written informed consent
• Willingness to participate in the study.

You may not qualify if:

• Age below 18 years
• Presence of other anal canal diseases (anal fissure, anal fistula, anorectal malignancy, inflammatory bowel disease involving the anorectal region, etc.)
• Previous anorectal surgery that may affect study outcomes
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Ali Genc: lead

MeSH Terms

Conditions

Pain, Postoperative; Hemorrhoids

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ali Genç, Assistant professor

CONTACT

+90-3562129500; aligenc0860@outlook.com

Muzaffer Katar, Associate Professor

CONTACT

0 (356) 212 95 00 - 7515; Muzaffer.katar@gop.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07