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Fluid Restriction After Stapled Hemorrhoidopexy

Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04459039
Enrollment
53
Registered
2020-07-07
Start date
2018-02-01
Completion date
2020-02-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Restriction

Keywords

Stapled hemorrhoidopexy, Fluid restriction, Urinary retention

Brief summary

BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain. PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.

Interventions

DRUG1000 mL 0.9% sterile saline

Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.

DRUG250 mL 0.9% sterile saline

Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Gr. III-IV hemorrhoids paitents

Exclusion criteria

* Age\<20 or \>80 * Allergy to NSAID or opoids * Impaired renal function * Pregnant or breast feeding

Design outcomes

Primary

MeasureTime frameDescription
first urination1 daythe time to first urination after surgery

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026