Fluid Restriction After Stapled Hemorrhoidopexy

NCT04459039 | Completed

• 1 other identifier: 2-106-05-063
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Restriction

Keywords

Stapled hemorrhoidopexy; Fluid restriction; Urinary retention

Outcome Measures

Primary Outcomes (1)

• first urination

  the time to first urination after surgery

  1 day

Study Arms (2)

Fluid restriction

EXPERIMENTAL

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

Drug: 1000 mL 0.9% sterile saline

Non-fluid restriction

PLACEBO COMPARATOR

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

Drug: 250 mL 0.9% sterile saline

Interventions

1000 mL 0.9% sterile saline DRUG

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

Fluid restriction

250 mL 0.9% sterile saline DRUG

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

Non-fluid restriction

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gr. III-IV hemorrhoids paitents

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

TW (1)