Ahmad
Al Mansurah, Egypt
NCT Number: NCT05891314
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Al Mansurah, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one group will have botox injection in the internal sphincter
Other names: Botulonium toxin injection
this group will have internal sphincterotomy
Other names: lateral internal sphincterotomy
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.
Time frame: 4-6weeks
return to daily activities without complaint
Mansoura University
Other
The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control: a Randomized Controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details