The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control.

NCT ID: NCT05891314

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-02-01

Brief Summary

Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment.

Conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. On the other hand, a few patients require surgical intervention. Surgery is indicated for those not responding to conservative management, those with grade III, and grade IV hemorrhoids.

Surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. The most radical operations with the best results are the Milligan-Morgan and Ferguson hemorrhoidectomy .

However, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. The cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (IAS) that becomes exposed after hemorrhoidectomy. The spasm of the IAS is considered the target to relieve pain post operatively. Lateral internal sphincterotomy (LIS) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. However, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial.

On the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing.

Our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.

Detailed Description

many procedures have been described to decrease the pain post hemorridectomy. Internal sphincterotomy Botox Injection giving strong analgesics

We aim to evaluate the efficacy of Botox and internal sphincterotomy in pain relief after hemorridectomy.

Conditions

Pain; Haemorriodectomy; Anal Sphincterotomy

Study Design

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

Study Groups

Botox injection post hemorridectomy

after piles excision this group will be subjected to botox injection in the internal sphincter

Group Type: ACTIVE_COMPARATOR

Botox Injectable Product

Intervention Type: PROCEDURE

one group will have botox injection in the internal sphincter

Internal sphincterotomy

Intervention Type: PROCEDURE

this group will have internal sphincterotomy

Hemorridectomy alone

Just hemorridectomy without botox injection(control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hemorridectomy plus internal sphincterotomy

after piles excision patients will undergo internal sphincterotomy

Group Type: ACTIVE_COMPARATOR

Botox Injectable Product

Intervention Type: PROCEDURE

one group will have botox injection in the internal sphincter

Internal sphincterotomy

Intervention Type: PROCEDURE

this group will have internal sphincterotomy

Interventions

Botox Injectable Product

one group will have botox injection in the internal sphincter

Intervention Type: PROCEDURE

Internal sphincterotomy

this group will have internal sphincterotomy

Intervention Type: PROCEDURE

Other Intervention Names

Botulonium toxin injection; lateral internal sphincterotomy

Eligibility Criteria

Inclusion Criteria

• Both sexes,
• aged between 18 and 70 years old.
• Grade III and IV hemorrhoids.
• Those with failed conservative treatment.

Exclusion Criteria

• surgically unfit patients due to multiple comorbidities,
• patients who need emergency operation for complicated hemorrhoids,
• patients with partial rectal prolapse
• patients with rectal varices due to portal hypertension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Sakr

consultant and lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmad

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

5678

Identifier Type: -

Identifier Source: org_study_id