Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

NCT05571202 | Completed

• 1 other identifier: CG22204A
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorectal Disorder

Keywords

anorectal surgery, hemorrhoid, anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• surgery complications

  0-30 days post operative days.

• anesthesia complications

  0-30 days post operative days.

Study Arms (2)

Anorectal surgery patient under general anesthesia plus local infiltration

Anorectal surgery patient under general anesthesia plus local infiltration

Procedure: General anesthesia plus local infiltration

Anorectal surgery patient under spinal anesthesia

Anorectal surgery patient under spinal anesthesia alone

Procedure: Spinal anesthesia

Interventions

General anesthesia plus local infiltration PROCEDURE

The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.

Anorectal surgery patient under general anesthesia plus local infiltration

Spinal anesthesia PROCEDURE

The eligible patients underwent anorectal surgery under spinal anesthesia alone.

Anorectal surgery patient under spinal anesthesia

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>20 years old patients
• ASA 1-2 patients
• Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.

You may not qualify if:

• Having known hypersensitivity to amide type local anesthetics
• Patients ASA \>=3
• Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
• Fournier gangrene patients
• Surgery due to previous complications

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Verterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Rectal Diseases; Hemorrhoids

Interventions

Anesthesia, General; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Chun-Yu Lin, M.D.

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: January 1, 2017
• Primary Completion: May 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

TW (1)