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Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease

NCT04881344 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-05-11

No results posted yet for this study

Summary

Hemorrhoidal disease is a frequent anorectal disorder and the main reason for a visit to a coloproctologist. Hemorrhoids are present in healthy individuals. However, they can become pathologic, manifesting with pain, prolapse, itching, bleeding or soiling. Initially, they can be managed conservatively. When this failed to cure the symptoms, surgical therapy is indicated. For grade II (hemorrhoids prolapsing during straining but reducing spontaneously) or grade III (hemorrhoids prolapsing during straining but requiring manual reduction), laser hemorrhoidoplasty or mucopexy are safe and efficient procedures to treat hemorrhoids. However, the optimal treatment is still under debate. Recently, a randomized controlled trial reported lower recurrence and faster return to work associated with laser therapy. We aimed to compare both therapies, to assess the benefits of laser therapy for the treatment of hemorrhoidal disease symptoms, using a validated score.

Conditions

Interventions

PROCEDURE

laser hemorrhoidoplasty

* Under local anesthetic (or general anesthetic if contraindications to local anesthetic), * A laser optic fiber connected to a diode platform (Leonardo, Biolitec AG, Jena, Germany) will be applied threw a anoscope. After making a 1-mm opening at the external border of hemorrhoid pocket, the fiber will be introduced in the hemorrhoidal tissue. Several pulses, each lasting for 1.2 s, with a 0.6-s pause between pulses, will be delivered to the tissue. * As a day-case procedure (or short-stay if medical or social factors precluded ambulatory intervention), * Postoperative care will consist of: normal diet, bulking laxatives, self-irrigation to the anal wound at six times per day and painkiller. Absence for work certificate will be made for 7 days for each patient and they will be told to return to work and normal daily activities as soon as they felt able.

PROCEDURE

mucopexy

* Threw an anoscope, the hemorrhoidal cushion will be sutured using a half-circle (size 26) needle with a 2-0 poliglecaprone (Monocryl®, Ethicon, USA). Then, a continuous suture will be performed on the mucosa of the anal canal, and will terminate above the dentate line. The hemorrhoidal artery will be ligated by this suture. Then, the ligation will be tied to realize the hemorrhoidopexy. * Same anesthetic technique and postoperative care as the intervention group. As a day-case procedure (or short-stay if medical or social factors precluded ambulatory intervention).

Sponsors & Collaborators

  • Ris Frederic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-07-31
Completion
2022-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881344 on ClinicalTrials.gov