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Search / Trial NCT06049524

Could Preoperative Assessment of Physical and Psychological Status Help Predict Pain After Anorectal Surgery?

Launched by CENTER OF ENDOUROLOGY "ENDOCENTER" · Sep 15, 2023

Trial Information

Current as of June 03, 2025

Not yet recruiting

Keywords

Postoperative Analgesia Preoperative Assessment Anorectal Surgery Pain Threshold Postoperative Pain Predictor

ClinConnect Summary

This clinical trial is exploring how physical and psychological factors can affect the level of pain patients experience after undergoing surgery for conditions like hemorrhoids, anal fissures, and other related issues. Researchers want to find out if understanding a patient's pain tolerance before surgery can help predict how much pain they might feel afterward. Participants will fill out questionnaires about their physical and emotional well-being before and after their surgery, and a test to measure their pain threshold will also be conducted.

To be eligible for this study, participants must be at least 18 years old and diagnosed with specific benign anorectal conditions that require surgery. They should not have any other diseases that cause pain or take medications that could affect pain perception. Participants can expect to be closely monitored during the study and will need to sign a consent form to take part. This research aims to identify risk factors for severe pain after surgery, which could ultimately help improve patient care in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Center Of Endourology "Endocenter"

The Center of Endourology "Endocenter" is a leading clinical trial sponsor dedicated to advancing minimally invasive surgical techniques and innovative therapies in urology. With a focus on endourology, the center conducts rigorous clinical research aimed at improving patient outcomes through the development and evaluation of cutting-edge medical devices and treatment protocols. Committed to excellence in patient care and research integrity, Endocenter collaborates with multidisciplinary teams to ensure the highest standards of safety and efficacy in all clinical trials, fostering advancements that benefit both healthcare professionals and patients alike.

Locations

Moscow, , Russian Federation

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported