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

Pain Clinical Trial

Official title:

The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891314
• Other study ID #: 5678
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Botox Injectable Product
one group will have botox injection in the internal sphincter
• Internal sphincterotomy
this group will have internal sphincterotomy

Locations

Country	Name	City	State
Egypt	Ahmad	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	according to the visual analogue scale (VAS), which contain 10 degrees, the lower the degree , the lower the score this means less pain.	2weeks
Secondary	Time taken to return to daily activities in days.	return to daily activities without complaint	4-6weeks