Status:
UNKNOWN
Could Preoperative Assessment of Physical and Psychological Status Help Predict Pain After Anorectal Surgery?
Lead Sponsor:
Center of Endourology "Endocenter"
Conditions:
Hemorrhoids
Anal Fistula
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this single-center prospective observational trial is to study the influence of physical and psychological factors on the intensity of pain syndrome after anorectal interventions and to det...
Detailed Description
This study is a single-center prospective observational study conducted on the basis of the surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University (MRE...
Eligibility Criteria
Inclusion
- Patients over 18 years old
- Diagnosed benign anorectal disease requiring surgical treatment: hemorrhoidal disease of stage 2-4, anal fissure that does not respond to conservative treatment, rectal and rectovaginal fistulas with or without drainage ligature, post-traumatic failure of the anal sphincter, as well as other types of failure of the anal sphincter.
- One of the planned interventions: open/closed hemorrhoidectomy with or without Ligasure, excision of the anal fissure, excision of the rectum or rectovaginal fistula of the rectum with or without segmental proctoplasty, sphincterolevatoroplasty or other options for reconstruction of the anal sphincter.
- Indications for planned surgical treatment
- Absence of other diseases that cause pain syndrome.
- I, II class of anesthetic risk according to ASA classification
- Voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial.
Exclusion
- The chronic pain syndrome unrelated to the main proctological disease, exacerbation of concomitant diseases with pain syndrome
- Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases.
- Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease.
- The presence of previously diagnosed mental and neurological disorders.
- Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention).
- Pregnant women
- Complicated course of the postoperative period
Key Trial Info
Start Date :
January 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06049524
Start Date
January 8 2024
End Date
December 30 2024
Last Update
October 6 2023
Active Locations (1)
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1
the surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University (MREC MSU)
Moscow, Russia, 119991