Fluid Restriction After Stapled Hemorrhoidopexy

Not Applicable

Completed

• Conditions: Fluid Restriction
• Interventions: Drug: 1000 mL 0.9% sterile saline; Drug: 250 mL 0.9% sterile saline

• Registration Number: NCT04459039
• Lead Sponsor: Tri-Service General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-02-01
• Study First Submitted: 2020-06-26
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Gr. III-IV hemorrhoids paitents

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid restriction	1000 mL 0.9% sterile saline	Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
Non-fluid restriction	250 mL 0.9% sterile saline	Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously

Primary Outcome Measures

Name	Time	Method
first urination	1 day	the time to first urination after surgery

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan