Proctoscopy Surgery
Conditions
Interventions
This is a randomized, double-blind clinical trial in which a total of 66 (sixty six) adult patients electively hospitalized with a diagnosis of hemorrhoidal disease will participate in the research fo
group I will undergo conventional open hemorrhoidectomy with intraoperative botulinum toxin insertion and group C will undergo conventional open hemorrhoidectomy without botulinum toxin insertion, wit
this evaluation will be based on clinical variables and results of complementary examinations considering the risks of cardiac and non-cardiac complications, based on the classification of the America
the participants will not know which group they are in, but the participant will know that there are two groups in the research and their respective interventions
to ensure the best implementation of blinding, the outcome assessor will be a physician who is not part of the research team
this measure can effectively prevent communication between patients and assessors receiving different treatments, thus improving the reliability of the clinical trial, the primary outcome will be the
secondary outcomes will be the amount of analgesia used by the participant postoperatively (use of ibuprofen 400 milligrams and dipyrone or parace
Sponsors
Fundacao do ABC
Fundacao do ABC
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both sexes; hospitalized for elective hemorrhoidectomy; grade III or IV hemorrhoidal disease with or without anal skin tags; 18 years of age or older; in agreement and sign the informed consent form
Exclusion criteria
Exclusion criteria: History of egg allergy; presence of uremia or impaired renal function; use of antibiotics; use of steroidal anti-inflammatory drugs; use of magnesium sulfate-based calcium channel blockers; use of anticoagulants; preoperative fecal incontinence; presence of other diseases such as anorectal fissure or fistula associated with hemorrhoidal disease; clinical suspicion of neoplastic lesion of the anal canal or associated with hemorrhoidal disease; pregnant or breastfeeding women; performance of another surgical technique for the treatment of hemorrhoidal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that patients receiving botulinum toxin may benefit from improved pain relief and, in turn, greater postoperative comfort. The primary outcome will be the subjective intensity of pain, measured daily by patients using a visual analog scale (VAS) from 0 to 10. This scale will be recorded from the immediate postoperative period (d0) until 7 consecutive days after hospital discharge (d1, d2, d3, d4, d5, d6, and d7) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe that patients receiving botulinum toxin require less analgesics compared to the control group. Secondary outcome will be the amount of analgesia used by the participant post-operatively (use of ibuprofen (400 mg) and dipyrone or paracetamol;It is expected to observe that patients receiving botulinum toxin require experience improved bowel movement patterns with a reduced need for laxatives compared to the control group;It is expected to observe that patients receiving botulinum toxin have a shorter healing time compared to the control group. Healing time will be defined as the interval between the day of the hemorrhoidectomy and the last outpatient visit for postoperative care;It is expected to observe that patients receiving botulinum toxin to experience less urinary retention compared to the control group;It is expected to observe that patients receiving botulinum toxin to experience to return to work activities more quickly compared to the control group;It is expected to observe that patients receiving botulinum toxin require a shorter hospital stay compared to the control group;Patients receiving botulinum toxin are expected to require less analgesics; less laxatives; have a shorter healing time; less urinary retention; a faster return to work; and a shorter hospital stay compared to the control group. Secondary outcomes will be the amount of analgesia used by the participant post-operatively (use of ibuprofen (400 mg) and dipyrone or paracetamol); the frequency of daily bowel movements; healing time; the need for laxatives; the presence of urinary retention; the time to return to work; and the length of post-operative hospital stay. Healing time will be defined as the interval between the last visit to the outpatient clinic for post-operative care and the day of the hemorrhoidectomy;Patients receiving botulinum toxin are expected to require less analgesics; less laxatives; have a shorter healing time; less urinary retention; a faster r | — |
Countries
BR
Contacts
Public ContactSandra Boratto
Fundacao do ABC
Outcome results
None listed