Menu
Not yet recruiting NCT07710053

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

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HAL + Mucopexy, HAL Alone.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Postoperative Pain and Tenesmus Between Doppler-Guided Hemorrhoidal Artery Ligation Alone and Doppler-Guided Hemorrhoidal Artery Ligation Combined With Mucopexy in Patients With Hemorrhoidal Disease

Overview

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.

Interventions

  • Procedure HAL + Mucopexy
    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.
  • Procedure HAL Alone
    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.

Primary outcome measures

  • Postoperative Pain Score (VAS) [Time frame: Postoperative Hour 8]
Secondary outcome measures (1)
  • Postoperative Pain Score [Time frame: 1 month after surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07710053 · 25-MOBAEK-080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗