NCT01276561

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

7 years

First QC Date

January 11, 2011

Last Update Submit

February 1, 2017

Conditions

Hereditary SpherocytosisIdiopathic Thrombocytopenic Purpura

Keywords

laparoscopysplenectomysingle sitetrial

Outcome Measures

Primary Outcomes (1)

  • Operative time

    operative time

    1 day

Secondary Outcomes (5)

  • operative complications

    1 day

  • wound complications

    1 month

  • cosmesis

    6 months

  • length of stay

    1 week

  • operative difficulty

    1 day

Study Arms (2)

Single Incision Splenectomy

ACTIVE COMPARATOR

Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used

Procedure: Single Incision Splenectomy

Laparoscopic Splenectomy

ACTIVE COMPARATOR

Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent

Procedure: Laparoscopic Splenectomy

Interventions

Single Incision SplenectomyPROCEDURE

Patients will undergo laparoscopic splenectomy through a single incision

Also known as: SILS
Single Incision Splenectomy
Laparoscopic SplenectomyPROCEDURE

Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent

Also known as: Standard
Laparoscopic Splenectomy

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Need for splenectomy

You may not qualify if:

  • Splenomegaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Spherocytosis, HereditaryPurpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPurpura, ThrombocytopenicPurpuraBlood Coagulation DisordersThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

October 1, 2009

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)