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

NCT06049524 | Unknown DMC

• 1 other identifier: 102458296
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 determine the association between the physiological pain threshold before surgery and the level of pain syndrome after anorectal surgery. Participants undergoing surgical treatment for anorectal diseases will be asked to complete the questionnaires before and after surgery, all information will be collected to identify risk factors for severe pain syndrome after surgery. The pain threshold test will be conducted to determine the association with pain after surgery.

Conditions

Hemorrhoids; Anal Fistula; Anal Fissure; Incontinence; Pain Syndrome; Postoperative Pain

Keywords

postoperative analgesia; preoperative assessment; anorectal surgery; pain threshold; postoperative pain predictor

Outcome Measures

Primary Outcomes (1)

• Correlation between the preoperative pain threshold level and the intensity of the postoperative pain syndrome

  The pain threshold is the point at which a subject begins to experience pain from an outward stimulus. The individual physiological level of pain threshold is assessed before surgery with a test determining the threshold for pressure pain. The intensity of the postoperative pain syndrome is assessed according to VAS scale during 15 days after surgery.

  Day 15 after surgery

Secondary Outcomes (10)

• The relationship between the physical factors and the intensity of the postoperative pain syndrome

  Day 15 after surgery

• The relationship between the preoperative clinical factors and the intensity of the postoperative pain syndrome

  Day 15 after surgery

• The relationship between the perioperative clinical factors and the intensity of the postoperative pain syndrome

  Day 15 after surgery

• The correlation between the severity of pain syndrome and psychological factors before surgery

  Before surgery

• The correlation between the severity of pain syndrome and psychological factors after surgery.

  Day 7 after surgery

Study Arms (1)

Experimental group

Prior to surgery all included patients are asked to fill out questionnaires in written or electronic form to collect the information. Then the participating doctor conducts a test to determine the pain threshold for pressure pain. Further the scheduled surgical intervention is performed under spinal anesthesia.Intraoperative data are also entered to the database. After surgery the researcher provides the patient with a written or electronic form of a postoperative monitoring questionnaire. In the postoperative period, patients undergo analgesia according to the standard scheme. In case of ineffectiveness of the standard anesthesia regimen 100 mg of tramadol is administered to the patient. All patients are remotely monitored 30 days after surgery to collect postoperative data, and if there are any remaining symptoms or complaints, they are invited to the clinic for examination.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Our clinic specializes only in the adult population
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age, who have been diagnosed with one of the benign anorectal diseases (hemorrhoidal disease of stage 2-4, anal fissure that does not respond to conservative treatment, rectal and rectovaginal fistulas, post-traumatic other types of the anal incontinence) and are intended for surgical treatment (open/closed hemorrhoidectomy with or without Ligasure, excision of the anal fissure, excision of the rectal or rectovaginal fistula with or without segmental proctoplasty, sphincterolevatoroplasty or other options for anal sphincter reconstruction) are potential participants in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Center of Endourology "Endocenter": lead

Study Sites (1)

the surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University (MREC MSU)

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Hemorrhoids; Rectal Fistula; Fissure in Ano; Somatoform Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Anus Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Tatiana Garmanova, PhD

CONTACT

+79773429249; tatianagarmanova@gmail.com

Ekaterina Kazachenko

CONTACT

ekaterina.k.97@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: September 22, 2023
• Study Start: January 8, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 30, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)