Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease

NCT04881344 | Unknown

• 1 other identifier: 2020-01375
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The laser hemorrhoidoplasty (laser group, intervention group)

EXPERIMENTAL

Procedure: laser hemorrhoidoplasty

The hemorrhoidopexy (mucopexy group, control group)

ACTIVE COMPARATOR

Procedure: mucopexy

Interventions

laser hemorrhoidoplasty PROCEDURE

* 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.

The laser hemorrhoidoplasty (laser group, intervention group)

mucopexy PROCEDURE

* 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).

The hemorrhoidopexy (mucopexy group, control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ris Frederic: lead

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gregoire Longchamp, M.D.

CONTACT

+41795530226; gregoire.longchamp@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor Frédéric Ris

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 11, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share