Clinical Trials Directory

Trials / Completed

CompletedNCT04459039

Fluid Restriction After Stapled Hemorrhoidopexy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
53 (actual)
Sponsor
Tri-Service General Hospital · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUG1000 mL 0.9% sterile salineWithin 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
DRUG250 mL 0.9% sterile salineWithin 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.

Timeline

Start date
2018-02-01
Primary completion
2019-12-01
Completion
2020-02-01
First posted
2020-07-07
Last updated
2020-07-07

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04459039. Inclusion in this directory is not an endorsement.