Fluid Restriction After Stapled Hemorrhoidopexy

NCT ID: NCT04459039

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Fluid restriction

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

Group Type: EXPERIMENTAL

1000 mL 0.9% sterile saline

Intervention Type: DRUG

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

Non-fluid restriction

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

Group Type: PLACEBO_COMPARATOR

250 mL 0.9% sterile saline

Intervention Type: DRUG

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

Interventions

1000 mL 0.9% sterile saline

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

Intervention Type: DRUG

250 mL 0.9% sterile saline

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi-Chiao Cheng

Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tri-Service General Hospital, National Defense Medical Center

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2-106-05-063

Identifier Type: -

Identifier Source: org_study_id