Non-Functioning KidneyNCT06134700
Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy
A study testing Laparoscopic Surgery in people with Non-Functioning Kidney and Renal Cell Carcinoma, run by Institute of medicine, Maharagjung medical campus.
Trial summary
Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Functioning Kidney, Renal Cell Carcinoma
- What is being tested?
- Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 15 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing laparoscopic nephrectomy
Who cannot join
- Age <18 years
- History of previous abdominal surgeries
- Laparoscopic donor nephrectomies
About this study
Official title: Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy: A Prospective Randomised Controlled Trial
Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies.
This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum
- Conditions
- Non-Functioning Kidney, Renal Cell Carcinoma
- Being tested
- Laparoscopic Surgery
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SurgeryProcedure or surgery
- Surgery will then proceed at either 8 - 10 or 12 - 15 mmHg pneumoperitoneum pressure depending on study group the patient falls into
- Port Placement
- Reflection of colon
- Isolation of ureterogonadal packet
- Upper pole dissection
- Hilar dissection
- Vessel clipping and division
- Dissection of kidney
- Delivery through either Pfannenstiel or iliac fossa incision
| Study group | Role | What they receive |
|---|---|---|
| Low pressure pneumoperitoneum laparoscopic nephrectomy | Experimental | Pneumoperitonuem Pressure of 8 - 10 mmHg Receives: Procedure: Laparoscopic Surgery |
| Standard pressure pneumoperitoneum laparoscopic nephrectomy | Active comparator | Pneumoperitonuem Pressure of 12 - 15 mmHg Receives: Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
Complications between two groups will determine the safety of procedure.
Measured: 30 days perioperative period
To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
Operative time will help to determine efficacy of treatment.
Measured: 30 days perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Functioning KidneyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of medicine, Maharagjung medical campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anjit Phuyal, Institute of medicine, Maharagjung medical campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134700
- Sponsor's protocol ID
- MaharagjungMC
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06134700
- Acronym / sponsor ID
- MaharagjungMC
- Conditions
- Non-Functioning Kidney, Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Institute of medicine, Maharagjung medical campusUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies.
This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pressure pneumoperitoneum laparoscopic nephrectomy | Experimental | Procedure: Laparoscopic SurgeryPneumoperitonuem Pressure of 8 - 10 mmHg |
| Standard pressure pneumoperitoneum laparoscopic nephrectomy | Active comparator | Procedure: Laparoscopic SurgeryPneumoperitonuem Pressure of 12 - 15 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing laparoscopic nephrectomy
Key exclusion criteria (3 listed)
- Age <18 years
- History of previous abdominal surgeries
- Laparoscopic donor nephrectomies
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 |
|---|---|---|
| Laparoscopic Surgery* Surgery will then proceed at either 8 - 10 or 12 - 15 mmHg pneumoperitoneum pressure depending on study group the patient falls into * Port Placement * Reflection of colon * Isolation of ureterogonadal packet * Upper pole dissection * Hilar dissection * Vessel clipping and division * Dissection of kidney * Delivery through either Pfannenstiel or iliac fossa incision | Procedure or surgery | Low pressure pneumoperitoneum laparoscopic nephrectomy, Standard pressure pneumoperitoneum laparoscopic nephrectomy |
Primary outcome
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
Time frame: 30 days perioperative period
Complications between two groups will determine the safety of procedure.
To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
Time frame: 30 days perioperative period
Operative time will help to determine efficacy of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Surgery in people with Non-Functioning Kidney and Renal Cell Carcinoma, run by Institute of medicine, Maharagjung medical campus.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy (time frame: 30 days perioperative period). The study lists 2 primary outcomes in all. 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 18 Nov 2023.