Fluid Restriction After Stapled Hemorrhoidopexy | NCT04459039

Studies
Fluid Restriction After Stapled Hemorrhoidopexy

NCT04459039

Sponsor

Tri-Service General Hospital (TSGH)

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Fluid Restriction

Interventions

1000 mL 0.9% sterile saline
250 mL 0.9% sterile saline

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Jun 26, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi-Chiao Cheng, Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Tri-Service General Hospital (TSGH)Principal Investigator

Lead Sponsor

Tri-Service General Hospital (TSGH)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
first urination	the time to first urination after surgery	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tri-Service General Hospital, National Defense Medical Center		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D016055	Urinary Retention

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided