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CompletedNCT05571202Updated Jan 31, 2023

Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

An observational study in Anorectal Disorder, sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Taichung Veterans General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,400
Ages
20 Years and older
Sex
All
01

Study 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.

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

  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
02

Conditions studied

  • Anorectal Disorder

Keywords

  • anorectal surgery, hemorrhoid, anesthesia
03

In context

Rectal Diseases

87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.

This study's enrollment of 1,400 is above the median of 223 across 26 observational studies indexed under Rectal Diseases.

Browse Rectal Diseases studies →

Lead sponsor

Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Having known to amide type local anesthetics
  • Patients ASA >=3
  • Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
  • Fournier gangrene patients
  • Surgery due to previous complications
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,400 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureGeneral anesthesia plus local infiltration

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

  • ProcedureSpinal anesthesia

    The eligible patients underwent anorectal surgery under spinal anesthesia alone.

06

What researchers measure

Primary outcomes

  1. Urine retention rate

    urine retention events needs foley catheterization

    Time frame: 0-24 hours post operation.

  2. Pain score

    Visual Analogue Scale (VAS)

    Time frame: 0-24 hours post operation.

Secondary outcomes

  1. surgery complications

    surgery complications

    Time frame: 0-30 days post operative days.

  2. anesthesia complications

    anesthesia complications rate

    Time frame: 0-30 days post operative days.

07

Study locations

1 site
  • Taichung Verterans General Hospital
    Taichung, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in May 2022, 64 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2022
First posted
Oct 7, 2022
StartActual
Jan 1, 2017
Primary completionActual
May 30, 2022
CompletionActual
Sep 30, 2022
Last update
Jan 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05571202
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
Jan 1, 2017
Primary completion
May 30, 2022
Completion
Sep 30, 2022
Last update
Jan 31, 2023

Study contacts

Chun-Yu Lin, M.D.
study director · Taichung Veterans General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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