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Completed

NCT Number: NCT05891314

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmad

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox Injectable Product

Procedure

one group will have botox injection in the internal sphincter

Other names: Botulonium toxin injection

Internal sphincterotomy

Procedure

this group will have internal sphincterotomy

Other names: lateral internal sphincterotomy

Primary outcomes

  1. Post-operative pain

    Time frame: 2weeks

    according to the visual analogue scale (VAS), which contain 10 degrees, the lower the degree , the lower the score this means less pain.

Secondary outcomes

  1. Time taken to return to daily activities in days.

    Time frame: 4-6weeks

    return to daily activities without complaint

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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