Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anorectal Disorder
• Intervention / Treatment: Procedure: General anesthesia plus local infiltration; Procedure: Spinal anesthesia

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

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

• Study Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Verterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anorectal surgery patient under general anesthesia plus local infiltration	Procedure: General anesthesia plus local infiltration; The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.
Anorectal surgery patient under spinal anesthesia; Anorectal surgery patient under spinal anesthesia alone	Procedure: Spinal anesthesia; The eligible patients underwent anorectal surgery under spinal anesthesia alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine retention rate	urine retention events needs foley catheterization	0-24 hours post operation.
Pain score	Visual Analogue Scale (VAS)	0-24 hours post operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery complications	surgery complications	0-30 days post operative days.
anesthesia complications	anesthesia complications rate	0-30 days post operative days.

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Director: Chun-Yu Lin, M.D., Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: anorectal surgery, hemorrhoid, anesthesia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CG22204A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No