- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07678814
Comparison of Laser Hemorrhoidoplasty Versus Conventional Milligan Morgan Hemorrhoidectomy in Grade II and III Hemorrhoids (LHP-MMH)
Comparison of Laser Hemorrhoidoplasty Versus Conventional Milligan Morgan Hemorrhoidectomy in Grade II and III Hemorrhoids: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This single-center randomized controlled trial was conducted in the Department of Surgery, Jinnah Hospital Lahore. Ninety-six patients diagnosed with Grade II or Grade III hemorrhoids were randomized into two equal groups.
Group A underwent Laser Hemorrhoidoplasty.
Group B underwent conventional Milligan Morgan Hemorrhoidectomy.
Patients were followed postoperatively for pain assessment using the Visual Analogue Scale (VAS), hospital stay, and patient satisfaction using a structured Likert-scale questionnaire.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Jinnah Hospital, Lahore.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Age ≥18 years Grade II hemorrhoids Grade III hemorrhoids Both genders
Exclusion Criteria:
Rectal prolapse Anal fissure Anorectal malignancy Pregnancy or lactating mothers
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Laser Hemorrhoidoplasty
Patients underwent Laser Hemorrhoidoplasty using diode laser energy applied to hemorrhoidal tissue.
|
Patients randomized to the intervention group underwent Laser Hemorrhoidoplasty under spinal anesthesia.
A diode laser probe was introduced into the hemorrhoidal tissue through a small mucosal entry point under direct visualization using an anoscope.
Controlled laser energy was delivered submucosally to achieve coagulation, shrinkage, and fixation of the hemorrhoidal cushions while preserving the surrounding anoderm and mucosa.
The procedure was performed according to standard surgical protocols with the aim of reducing postoperative pain, bleeding, and recovery time.
|
|
Aktiv komparator: Milligan Morgan Hemorrhoidectomy
Patients underwent conventional open Milligan Morgan Hemorrhoidectomy.
|
Patients randomized to the control group underwent conventional open Milligan Morgan Hemorrhoidectomy under spinal anesthesia.
The hemorrhoidal pedicles were identified, ligated, and excised using standard surgical techniques.
The wounds were left open with preservation of mucocutaneous bridges between excision sites.
Hemostasis was achieved as required.
Patients received routine postoperative care and follow-up according to institutional protocols.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain
Tidsramme: Post Operative period: (6) Six Hourly in first 48 Hours, at 1 week post operative period & at 1 month post operatively.
|
Pain measured using Visual Analogue Scale (VAS).
|
Post Operative period: (6) Six Hourly in first 48 Hours, at 1 week post operative period & at 1 month post operatively.
|
|
Patient Satisfaction
Tidsramme: 1 month postoperative
|
Patient satisfaction assessed using Likert-scale questionnaire.
|
1 month postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ERB166 / 9 / 11-06-2024/S1 ERB
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .