Fluid Restriction After Stapled Hemorrhoidopexy

Fluid Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459039
• Other study ID #: 2-106-05-063
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2020
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Restriction

Intervention

Drug:
• 1000 mL 0.9% sterile saline
Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
• 250 mL 0.9% sterile saline
Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first urination	the time to first urination after surgery	1 day