Anorectal DisorderNCT05571202
Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery
An observational study of Anorectal Disorder, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anorectal Disorder
- What is being tested?
- General anesthesia plus local infiltration and Spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Benign anorectal disease patients underwent surgery interventions. Characteristics of age, gender, height, weight, ASA score, past medical history, operational history were recorded from EHIS systems. Intraoperative findings which include anesthesia time, operation time, intraoperative fluid. Surgical outcomes include surgery complications, anesthesia complications, pain score. All of above data were retrospective recorded from hospital discharge note, OPD records, operation note, pathology report.
Who may be able to join
- >20 years old patients
- ASA 1-2 patients
- Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.
Who cannot join
- Having known hypersensitivity to amide type local anesthetics
- Patients ASA >=3
- Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
- Fournier gangrene patients
- Surgery due to previous complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Score and Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery, Retrospective Observation Study
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.
Read the detailed description
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Deep level of anesthesia is required for these surgeries. Excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. Various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. Among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.
Inclusion Criteria:
- >20 years old patients
- ASA 1-2 patients
- Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.
Exclusion Criteria:
- Having known hypersensitivity to amide type local anesthetics
- Patients ASA >=3
- Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
- Fournier gangrene patients
- Surgery due to previous complications.
Characteristic data
- Age, Gender, ASA class,
- Past history: medical history, surgical history
- Previous anorectal history
- Type of anorectal surgery, number of hemorrhoidectomy
- Methods of anesthesia, posture during surgery
- Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, >9 can discharge)
- Ward record: vital sign and urine retention need foley catherization
- Conditions
- Anorectal Disorder
- Being tested
- General anesthesia plus local infiltration, Spinal anesthesia
- Keywords
- anorectal surgery, hemorrhoid, anesthesia
- Medical subject headings
- Rectal Diseases, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia plus local infiltrationProcedure or surgery
The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.
Spinal anesthesiaProcedure or surgery
The eligible patients underwent anorectal surgery under spinal anesthesia alone.
| Study group | Role | What they receive |
|---|---|---|
| Anorectal surgery patient under general anesthesia plus local infiltration | Anorectal surgery patient under general anesthesia plus local infiltration Receives: Procedure: General anesthesia plus local infiltration | |
| Anorectal surgery patient under spinal anesthesia | Anorectal surgery patient under spinal anesthesia alone Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine retention rate
urine retention events needs foley catheterization
Measured: 0-24 hours post operation.
Pain score
Visual Analogue Scale (VAS)
Measured: 0-24 hours post operation.
Secondary outcomes (2)
surgery complications
surgery complications
Measured: 0-30 days post operative days.
anesthesia complications
anesthesia complications rate
Measured: 0-30 days post operative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jan 2017
- Primary completion30 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal DisorderStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Lin, M.D., Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571202
- Sponsor's protocol ID
- CG22204A
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Score and Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery, Retrospective Observation Study
- ClinicalTrials.gov ID
- NCT05571202
- Acronym / sponsor ID
- CG22204A
- Conditions
- Anorectal Disorder
- Keywords
- anorectal surgery, hemorrhoid, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.
Detailed description
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Deep level of anesthesia is required for these surgeries. Excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. Various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. Among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.
Inclusion Criteria:
- >20 years old patients
- ASA 1-2 patients
- Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.
Exclusion Criteria:
- Having known hypersensitivity to amide type local anesthetics
- Patients ASA >=3
- Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
- Fournier gangrene patients
- Surgery due to previous complications.
Characteristic data
- Age, Gender, ASA class,
- Past history: medical history, surgical history
- Previous anorectal history
- Type of anorectal surgery, number of hemorrhoidectomy
- Methods of anesthesia, posture during surgery
- Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, >9 can discharge)
- Ward record: vital sign and urine retention need foley catherization
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorectal surgery patient under general anesthesia plus local infiltration | – | Procedure: General anesthesia plus local infiltrationAnorectal surgery patient under general anesthesia plus local infiltration |
| Anorectal surgery patient under spinal anesthesia | – | Procedure: Spinal anesthesiaAnorectal surgery patient under spinal anesthesia alone |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Benign anorectal disease patients underwent surgery interventions. Characteristics of age, gender, height, weight, ASA score, past medical history, operational history were recorded from EHIS systems. Intraoperative findings which include anesthesia time, operation time, intraoperative fluid. Surgical outcomes include surgery complications, anesthesia complications, pain score. All of above data were retrospective recorded from hospital discharge note, OPD records, operation note, pathology report.
Key inclusion criteria (3 listed)
- >20 years old patients
- ASA 1-2 patients
- Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.
Key exclusion criteria (5 listed)
- Having known hypersensitivity to amide type local anesthetics
- Patients ASA >=3
- Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
- Fournier gangrene patients
- Surgery due to previous complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesia plus local infiltrationThe eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics. | Procedure or surgery | Anorectal surgery patient under general anesthesia plus local infiltration |
| Spinal anesthesiaThe eligible patients underwent anorectal surgery under spinal anesthesia alone. | Procedure or surgery | Anorectal surgery patient under spinal anesthesia |
Primary outcome
Urine retention rate
Time frame: 0-24 hours post operation.
urine retention events needs foley catheterization
Pain score
Time frame: 0-24 hours post operation.
Visual Analogue Scale (VAS)
2 secondary outcomes
surgery complications
Time frame: 0-30 days post operative days.
anesthesia complications
Time frame: 0-30 days post operative days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Lin, M.D. study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Disorder, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine retention rate (time frame: 0-24 hours post operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.