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

Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease, a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: laser hemorrhoidoplasty; Procedure: mucopexy

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregoire Longchamp, M.D.; Phone Number: +41795530226; Email: gregoire.longchamp@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The laser hemorrhoidoplasty (laser group, intervention group)	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.
Active Comparator: The hemorrhoidopexy (mucopexy group, control group)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Symptom Score	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).	6 postoperative months

Collaborators and Investigators

• Sponsor: Ris Frederic

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 2020-01375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No