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Postoperative Pain and Tenesmus After Doppler-Guided Hemorrhoidal Artery Ligation With or Without Mucopexy
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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ali Genç, Assistant professor
- Telefoonnummer: +90-5442280060 +90-3562129500
- E-mail: aligenc0860@outlook.com
Studie Contact Back-up
- Naam: Muzaffer Katar, Associate Professor
- Telefoonnummer: 0 (356) 212 95 00 - 7515
- E-mail: Muzaffer.katar@gop.edu.tr
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: HAL + Mucopexy
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.
|
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.
|
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Actieve vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Pain Score (VAS)
Tijdsspanne: Postoperative Hour 8
|
Assessment of pain severity using the Visual Analog Scale (VAS) at the 8th postoperative hour.
|
Postoperative Hour 8
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Pain Score
Tijdsspanne: 1 month after surgery
|
Assessment of pain severity using the Visual Analog Scale (VAS) at the 1st postoperative month.
|
1 month after surgery
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Vaatziekten
- Hart-en vaatziekten
- Postoperatieve complicaties
- Pathologische processen
- Darmziekten
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Rectale ziekten
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn, postoperatief
- Aambeien
Andere studie-ID-nummers
- 25-MOBAEK-080
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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