Hereditary SpherocytosisNCT01276561
Single Incision Versus Standard Laparoscopic Splenectomy
A study testing Single Incision Splenectomy and Laparoscopic Splenectomy in people with Hereditary Spherocytosis and Idiopathic Thrombocytopenic Purpura, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy. The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hereditary Spherocytosis, Idiopathic Thrombocytopenic Purpura
- What is being tested?
- Single Incision Splenectomy and Laparoscopic Splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2017
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Need for splenectomy
Who cannot join
- Splenomegaly
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.
The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.
Read the detailed description
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. We will offer enrollment to several institutions provided they reach institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by definition. This is recorded and reported in MINUTES.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
Secondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.
- Being tested
- Single Incision Splenectomy, Laparoscopic Splenectomy
- Keywords
- laparoscopy, splenectomy, single site, trial
- Medical subject headings
- Spherocytosis, Hereditary, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision SplenectomyProcedure or surgery
Also called SILS
Patients will undergo laparoscopic splenectomy through a single incision
Laparoscopic SplenectomyProcedure or surgery
Also called Standard
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
| Study group | Role | What they receive |
|---|---|---|
| Single Incision Splenectomy | Active comparator | Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used Receives: Procedure: Single Incision Splenectomy |
| Laparoscopic Splenectomy | Active comparator | Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent Receives: Procedure: Laparoscopic Splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
operative time
Measured: 1 day
Secondary outcomes (5)
operative complications
Measured: 1 day
wound complications
Measured: 1 month
cosmesis
Measured: 6 months
length of stay
Measured: 1 week
operative difficulty
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2016
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary SpherocytosisStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276561
- Sponsor's protocol ID
- 09 09 196
- Status last verified
- Feb 2017
- First submitted
- 11 Jan 2011
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Versus Standard Laparoscopic Splenectomy
- ClinicalTrials.gov ID
- NCT01276561
- Acronym / sponsor ID
- 09 09 196
- Keywords
- laparoscopy, splenectomy, single site, trial
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Jan 2011 (estimated)
- 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.
This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.
The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.
Detailed description
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. We will offer enrollment to several institutions provided they reach institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by definition. This is recorded and reported in MINUTES.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
Secondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Incision Splenectomy | Active comparator | Procedure: Single Incision SplenectomyPatients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used |
| Laparoscopic Splenectomy | Active comparator | Procedure: Laparoscopic SplenectomyPatient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Need for splenectomy
Key exclusion criteria (1 listed)
- Splenomegaly
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 |
|---|---|---|
| Single Incision SplenectomyAlso: SILSPatients will undergo laparoscopic splenectomy through a single incision | Procedure or surgery | Single Incision Splenectomy |
| Laparoscopic SplenectomyAlso: StandardPatients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent | Procedure or surgery | Laparoscopic Splenectomy |
Primary outcome
Operative time
Time frame: 1 day
operative time
5 secondary outcomes
operative complications
Time frame: 1 day
wound complications
Time frame: 1 month
cosmesis
Time frame: 6 months
length of stay
Time frame: 1 week
operative difficulty
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Individual participant dataSharing planned: No
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Splenectomy
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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Incision Splenectomy and Laparoscopic Splenectomy in people with Hereditary Spherocytosis and Idiopathic Thrombocytopenic Purpura, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 3 Feb 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Operative time (time frame: 1 day). 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 3 Feb 2017.