Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- first urination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Fluid restriction
Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
Intervention: 1000 mL 0.9% sterile saline (Drug)
Non-fluid restriction
Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously
Intervention: 250 mL 0.9% sterile saline (Drug)
Outcomes
Primary Outcomes
first urination
Time Frame: 1 day
the time to first urination after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Yi-Chiao Cheng
Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center
Tri-Service General Hospital