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

NCT05891314 | Completed

• 1 other identifier: 5678
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Haemorriodectomy; Anal Sphincterotomy

Keywords

post hemorridectomy pain; sphincterotomy; botox injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time taken to return to daily activities in days.

  4-6weeks

Study Arms (3)

Botox injection post hemorridectomy

ACTIVE COMPARATOR

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

Procedure: Botox Injectable Product; Procedure: Internal sphincterotomy

Hemorridectomy alone

NO INTERVENTION

Just hemorridectomy without botox injection(control group)

Hemorridectomy plus internal sphincterotomy

ACTIVE COMPARATOR

after piles excision patients will undergo internal sphincterotomy

Procedure: Botox Injectable Product; Procedure: Internal sphincterotomy

Interventions

Botox Injectable Product PROCEDURE

one group will have botox injection in the internal sphincter

Also known as: Botulonium toxin injection

Botox injection post hemorridectomy; Hemorridectomy plus internal sphincterotomy

Internal sphincterotomy PROCEDURE

this group will have internal sphincterotomy

Also known as: lateral internal sphincterotomy

Botox injection post hemorridectomy; Hemorridectomy plus internal sphincterotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ahmad

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Lateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant and lecturer of general surgery

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: December 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: February 1, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

EG (1)