An observational study in Hemorrhoids, Anal Fistula and Anal Fissure, sponsored by Center of Endourology "Endocenter". Not yet recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Center of Endourology "Endocenter" · Observational
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.
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 (MREC MSU). Patients, 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. In case of meeting the inclusion criteria and after signing a voluntary informed consent to participate by the patient all the necessary information about the participating patient was entered into an electronic database. Prior to surgery the patient is asked to fill out questionnaires in written or electronic form to collect the following information:
All patients included in the study are scheduled to undergo appropriate surgical intervention under spinal anesthesia (SMA), performed according to the standard procedure. Next, the appropriate surgical treatment is performed. In case of changes in the type of anesthesia and the volume of the operation that do not meet the stated inclusion criteria, the patient is excluded from the study. Intraoperative data are also entered to the database: the final diagnosis, the type of surgical treatment, in the case of hemorrhoidectomy - the number of removed hemorrhoids.
After waking up in the ward, the researcher provides the patient-participant with a written or electronic form of a postoperative monitoring questionnaire, including parameters for assessing:
The primary endpoint is to determine the relationship between the preoperative pain threshold level and the intensity of the postoperative pain syndrome.
Secondary endpoints include identifying predictors of the development of moderate and severe pain syndrome (pain level 5-10 points according to VAS) among physical, clinical and psychological factors, as well as determining the correlation between the severity of pain syndrome and the level of anxiety and depression after surgery.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 47 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Center of Endourology "Endocenter" is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
The chronic pain syndrome unrelated to the main proctological disease, exacerbation of concomitant diseases with pain syndrome
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.
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.
Time frame: Day 15 after surgery
The relationship between the physical factors and the intensity of the postoperative pain syndrome
Identification of predictors of the development of moderate and severe pain syndrome (pain level 5-10 points according to VAS) among physical factors (gender, age, BMI, smoking experience and smoking index)
Time frame: Day 15 after surgery
The relationship between the preoperative clinical factors and the intensity of the postoperative pain syndrome
Identification of predictors of the development of moderate and severe pain syndrome (pain level 5-10 points according to VAS) among preoperative clinical factors (symptoms of the existing disease, in case of pain - pain assessment according to VAS, duration of the disease, analgesics usage, previous interventions in the anorectal area, relapses of the disease, the day of the menstrual cycle in women, duration of the menstrual cycle, hormonal contraceptives usage, a history of new coronavirus infection (COVID-19 infection), the date and duration of the COVID-19 infection)
Time frame: Day 15 after surgery
The relationship between the perioperative clinical factors and the intensity of the postoperative pain syndrome
Identification of predictors of the development of moderate and severe pain syndrome (pain level 5-10 points according to VAS) among preoperative clinical factors (the final diagnosis, the type of surgical treatment, in the case of hemorrhoidectomy - the number of removed hemorrhoids)
Time frame: Day 15 after surgery
The correlation between the severity of pain syndrome and psychological factors before surgery
Psychological factors include anxiety and depression. To assess anxiety and depressive syndrome, the scales for self-assessment of anxiety SAS (The Zung Self-Rating Anxiety Scale) and depression SDS (The Zung Self-Rating Depression Scale) is used.
Time frame: Before surgery
The correlation between the severity of pain syndrome and psychological factors after surgery.
Psychological factors include anxiety and depression. To assess anxiety and depressive syndrome, the scales for self-assessment of anxiety SAS (The Zung Self-Rating Anxiety Scale) and depression SDS (The Zung Self-Rating Depression Scale) is used.
Time frame: Day 7 after surgery
The correlation between the severity of pain syndrome and psychological factors after surgery.
Psychological factors include anxiety and depression. To assess anxiety and depressive syndrome, the scales for self-assessment of anxiety SAS (The Zung Self-Rating Anxiety Scale) and depression SDS (The Zung Self-Rating Depression Scale) is used.
Time frame: Day 30 after surgery
Analgesics usage
The frequency of administration and the number of analgesics taken, including opioids
Time frame: During 7 days after surgery
Pain Disability
If patient has a pain caused by anorectal disease, the impact of the pain on the quality of life will be evaluated according to the scale of assessment of the degree of disability due to pain (Pain Disability Index).
Time frame: Before surgery
Pain Disability
The impact of postoperative pain on the quality of life is evaluated according to the scale of assessment of the degree of disability due to pain (Pain Disability Index).
Time frame: Day 7 after surgery
Pain Disability
The impact of postoperative pain on the quality of life is evaluated according to the scale of assessment of the degree of disability due to pain (Pain Disability Index).
Time frame: Day 30 after surgery
Plan to share: No
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Center of Endourology "Endocenter"