Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease

NCT ID: NCT04881344

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The laser hemorrhoidoplasty (laser group, intervention group)

Group Type: EXPERIMENTAL

laser hemorrhoidoplasty

Intervention Type: 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 hemorrhoidopexy (mucopexy group, control group)

Group Type: ACTIVE_COMPARATOR

mucopexy

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ris Frederic

OTHER

Sponsor Role: lead

Responsible Party

Ris Frederic

Clinical Professor Frédéric Ris

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Gregoire Longchamp, M.D.

Role: CONTACT

gregoire.longchamp@hcuge.ch

+41795530226

Other Identifiers

2020-01375

Identifier Type: -

Identifier Source: org_study_id