Laparoscopic Liver LobectomyNCT07733609
Early Urinary Catheter Removal in Enhanced Recovery After Surgery for Laparoscopic Hepatectomy
A study testing structured multidisciplinary Enhanced Recovery and conventional perioperative care established by the Hepatobiliary Surgery Department in people with Laparoscopic Liver Lobectomy, run by Yu Zhang at 1 site in China.
Trial summary
The primary aim was to assess the impact of early catheter removal on postoperative urinary function, urinary complications, and recovery milestones. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Liver Lobectomy
- What is being tested?
- structured multidisciplinary Enhanced Recovery and conventional perioperative care established by the Hepatobiliary Surgery Department
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Early Urinary Catheter Removal in Enhanced Recovery After Surgery for Laparoscopic Hepatectomy: A Randomized Controlled Trial
The primary aim was to assess the impact of early catheter removal on postoperative urinary function, urinary complications, and recovery milestones.
- Conditions
- Laparoscopic Liver Lobectomy
- Being tested
- structured multidisciplinary Enhanced Recovery, conventional perioperative care established by the Hepatobiliary Surgery Department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured multidisciplinary Enhanced RecoveryProcedure or surgery
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.
conventional perioperative care established by the Hepatobiliary Surgery DepartmentProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Procedure: structured multidisciplinary Enhanced Recovery |
| Control Group | Active comparator | Not described Receives: Procedure: conventional perioperative care established by the Hepatobiliary Surgery Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of urinary catheter indwelling (hours)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Liver LobectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Zhang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733609
- Sponsor's protocol ID
- 2025-597-01
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Urinary Catheter Removal in Enhanced Recovery After Surgery for Laparoscopic Hepatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07733609
- Acronym / sponsor ID
- 2025-597-01
- Conditions
- Laparoscopic Liver Lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Yu ZhangUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim was to assess the impact of early catheter removal on postoperative urinary function, urinary complications, and recovery milestones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: structured multidisciplinary Enhanced Recovery |
| Control Group | Active comparator | Procedure: conventional perioperative care established by the Hepatobiliary Surgery Department |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured multidisciplinary Enhanced RecoveryParticipants 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. | Procedure or surgery | Experimental group |
| conventional perioperative care established by the Hepatobiliary Surgery DepartmentParticipants 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). | Procedure or surgery | Control Group |
Primary outcome
Duration of urinary catheter indwelling (hours)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured multidisciplinary Enhanced Recovery and conventional perioperative care established by the Hepatobiliary Surgery Department in people with Laparoscopic Liver Lobectomy, run by Yu Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of urinary catheter indwelling (hours) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.