Could Preoperative Assessment of Physical and Psychological Status Help Predict Pain After Anorectal Surgery?
NCT ID: NCT06049524
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2024-01-08
2024-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pre-Emptive Analgesia in Ano-Rectal Surgery
NCT02402543
Multi-Drug Analgesia vs. Standard Solution for Anal Surgery
NCT03105674
Psychiatric Disorder in Anorectal Dyssynergia
NCT06128031
IntraopeRativE Use of periNeal Block for Hemorrhoidectomy
NCT04288349
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
NCT06798155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* demographic data: gender, age, BMI, length of smoking and smoking index
* clinical data: symptoms of the disease, in case of pain - pain assessment according to the visual analog scale (VAS), duration of the disease, analgesics intake, previous interventions in the anorectal region, disease recurrences, the day of the menstrual cycle for women, duration of the menstrual cycle, hormonal medication intake, a previously experienced the new coronavirus infection (COVID infection-19), the duration of the COVID-19 infection
* psycho-emotional status: questionnaires to identify anxiety and depression
* A scale for assessing the degree of disability due to pain After the completion of the preoperative assessment, the participating doctor conducts a test to determine the pain threshold for pressure pain: a sphygmomanometer cuff is put on the non-working arm in a sitting position, and then inflated to 250 mm Hg and then the patient assesses the pain according to the VAS scale. If there is a sharp severe pain before the cuff is inflated to 250 mm Hg, the test ends, the test result is regarded as the maximum (10 points according to the VAS scale). All results are entered by the research doctor into the database.
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 severity of pain at rest (at the peak and after taking the analgesic) and pain during defecation on the VAS scale for 15 days after surgery
* the frequency of administration and the number of analgesics taken, including narcotic, within 7 days after surgery
* scale of the degree of disability assessment due to pain (Pain Disability Index) for evaluation on the 7th and 30th day after surgery
* questionnaires to determine anxiety and depression for evaluation on the 7th and 30th day after surgery In the postoperative period, patients undergo analgesia according to the scheme: 1000 mg of acetaminophen every 12 hours, 30 mg / m of ketorol every 8 hours. In case of ineffectiveness of the standard anesthesia regimen and the pain syndrome about 7-10 points according to VAS, 100 mg of tramadol is administered intramuscularly to the patient. If it is necessary (after excision of the fistula, sphincterolevatoroplasty), the debridement is performed at least 1 time a day. 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. If the patient does not come to the appointment, the researcher contacts him by all available means (phone or email) to clarify all the necessary data for the study. If the researcher fails to contact the patient, the patient is considered lost for follow-up and is excluded from the study.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center of Endourology "Endocenter"
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University (MREC MSU)
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
102458296
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.