Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease

Not Applicable

• Conditions: Hemorrhoids
• Interventions: Procedure: laser hemorrhoidoplasty; Procedure: mucopexy

• Registration Number: NCT04881344
• Lead Sponsor: Ris Frederic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11
• Study Start: 2021-06
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The laser hemorrhoidoplasty (laser group, intervention group)	laser hemorrhoidoplasty	-
The hemorrhoidopexy (mucopexy group, control group)	mucopexy	-

Primary Outcome Measures

Name	Time	Method
The Symptom Score	6 postoperative months	The primary outcome will be the "Symptom Score" at six postoperative months. This score ranges from 0 to 15 points, based on each of the five cardinal symptoms of hemorrhoidal disease (pain, itching, bleeding, discharge and prolapse) attributed from 0 to 3 points according to the frequency of their manifestation (0 point: never, 1 point: \> 1x/month, \<1x/week, 2 points: 1-6x/week, 3 points: 1x/day).