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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05571202
Other study ID # CG22204A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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 1. Age, Gender, ASA class, 2. Past history: medical history, surgical history 3. Previous anorectal history 4. Type of anorectal surgery, number of hemorrhoidectomy 5. Methods of anesthesia, posture during surgery 6. Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, >9 can discharge) 7. Ward record: vital sign and urine retention need foley catherization


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date September 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
General anesthesia plus local infiltration
The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.
Spinal anesthesia
The eligible patients underwent anorectal surgery under spinal anesthesia alone.

Locations

Country Name City State
Taiwan Taichung Verterans General Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine retention rate urine retention events needs foley catheterization 0-24 hours post operation.
Primary Pain score Visual Analogue Scale (VAS) 0-24 hours post operation.
Secondary surgery complications surgery complications 0-30 days post operative days.
Secondary anesthesia complications anesthesia complications rate 0-30 days post operative days.
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