Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease (MuLa)

Ris Frederic

Status: Unknown

Conditions: Hemorrhoids

Treatments: Procedure: mucopexy; Procedure: laser hemorrhoidoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04881344

2020-01375

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed Consent as documented by signature
• Hemorrhoidal disease grade II to III unresponsive to medical therapy
• Age ≥18

Exclusion criteria

• Inability to follow the procedures of the study,
• Enrollment of the investigator, his/her family members, employees and other dependent persons,
• Anesthesiology contraindications to surgery,
• Emergency situation,
• Hemorrhoids associated with pregnancy,
• Oher surgical intervention performed at the same time of the hemorrhoids treatment,
• Concomitant anorectal disorders (fissure, fistula), thrombosed hemorrhoid,
• Previous pelvic radiotherapy, previous proctologic intervention during the last three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

The laser hemorrhoidoplasty (laser group, intervention group)

Experimental group

Treatment:

Procedure: laser hemorrhoidoplasty

The hemorrhoidopexy (mucopexy group, control group)

Active Comparator group

Treatment:

Procedure: mucopexy