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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Haemorriodectomy; Anal Sphincterotomy
• Intervention / Treatment: Procedure: Botox Injectable Product; Procedure: Internal sphincterotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Ahmad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox injection post hemorridectomy; after piles excision this group will be subjected to botox injection in the internal sphincter	Procedure: Botox Injectable Product; one group will have botox injection in the internal sphincter; Other Names: Botulonium toxin injection; Procedure: Internal sphincterotomy; this group will have internal sphincterotomy; Other Names: lateral internal sphincterotomy
No Intervention: Hemorridectomy alone; Just hemorridectomy without botox injection(control group)
Active Comparator: Hemorridectomy plus internal sphincterotomy; after piles excision patients will undergo internal sphincterotomy	Procedure: Botox Injectable Product; one group will have botox injection in the internal sphincter; Other Names: Botulonium toxin injection; Procedure: Internal sphincterotomy; this group will have internal sphincterotomy; Other Names: lateral internal sphincterotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to return to daily activities in days.	return to daily activities without complaint	4-6weeks

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sphincterotomy; botox injection; post hemorridectomy pain
• Other Study ID Numbers: 5678

Drug and device information, study documents

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