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Single Incision Versus Standard Laparoscopic Splenectomy

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ClinicalTrials.gov Identifier: NCT01276561
Recruitment Status : Withdrawn
First Posted : January 13, 2011
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Brief 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. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.


Condition or disease Intervention/treatment Phase
Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura Procedure: Single Incision Splenectomy Procedure: Laparoscopic Splenectomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Versus Standard Laparoscopic Splenectomy
Study Start Date : October 2009
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : April 2017


Arm Intervention/treatment
Active Comparator: Single Incision Splenectomy
Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
Procedure: Single Incision Splenectomy
Patients will undergo laparoscopic splenectomy through a single incision
Other Name: SILS
Active Comparator: Laparoscopic Splenectomy
Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
Procedure: Laparoscopic Splenectomy
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
Other Name: Standard



Primary Outcome Measures :
  1. Operative time [ Time Frame: 1 day ]
    operative time


Secondary Outcome Measures :
  1. operative complications [ Time Frame: 1 day ]
  2. wound complications [ Time Frame: 1 month ]
  3. cosmesis [ Time Frame: 6 months ]
  4. length of stay [ Time Frame: 1 week ]
  5. operative difficulty [ Time Frame: 1 day ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for splenectomy

Exclusion Criteria:

  • Splenomegaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276561


Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City

Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01276561     History of Changes
Other Study ID Numbers: 09 09 196
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
laparoscopy
splenectomy
single site
trial

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Spherocytosis, Hereditary
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Genetic Diseases, Inborn