NCT07733609

Brief Summary

The primary aim was to assess the impact of early catheter removal on postoperative urinary function, urinary complications, and recovery milestones.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of urinary catheter indwelling (hours)

    7 days

Study Arms (2)

Experimental group

EXPERIMENTAL
Procedure: structured multidisciplinary Enhanced Recovery

Control Group

ACTIVE COMPARATOR
Procedure: conventional perioperative care established by the Hepatobiliary Surgery Department

Interventions

Participants received a structured multidisciplinary Enhanced Recovery After Surgery (ERAS) program. Key interventions: preoperative education with an ERAS diary, shortened fasting with oral carbohydrate loading, opioid-sparing multimodal anesthesia, normothermia maintenance, and no routine abdominal drainage. Postoperatively, the urinary catheter was removed within 6 hours, with early oral hydration beginning 2 hours postoperatively, assisted ambulation within 6 hours, multimodal analgesia, and restrictive fluid management.

Experimental group

Participants received conventional perioperative care established by the Hepatobiliary Surgery Department, including routine preoperative fasting (≥8 h for solids, ≥6 h for fluids) without carbohydrate loading, standard balanced general anesthesia, routine abdominal drainage, opioid-based analgesia as needed, fasting for 6 hours postoperatively, oral intake initiated on postoperative day (POD) 1, and urinary catheter removal at approximately 24 hours postoperatively (POD 1).

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75 years.
  • Preoperative diagnosis of benign or malignant liver tumors, with a plan for standard laparoscopic liver lobectomy.
  • Liver function classified as Child-Pugh grade A.
  • Indocyanine green (ICG) 15-minute retention rate (ICG R15) \< 14%.
  • American Society of Anesthesiologists (ASA) physical status classification I-III.
  • Normal preoperative urinary function (residual urine volume \< 50 mL).
  • Provision of written informed consent.

You may not qualify if:

  • Emergency surgery or conversion to an open surgical procedure.
  • Concurrent neurogenic bladder or chronic urinary tract infection.
  • Planned transfer to the intensive care unit (ICU) following surgery.
  • Anticipated intraoperative blood loss exceeding 1000 mL.
  • Presence of urethral stricture or complications related to intraoperative catheterization.
  • Unwillingness to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start

September 1, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations