Single Incision Versus Standard Laparoscopic Splenectomy

NCT ID: NCT01276561

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2017-04-30

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.

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.

Conditions

Hereditary Spherocytosis; Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Incision Splenectomy

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

Group Type: ACTIVE_COMPARATOR

Single Incision Splenectomy

Intervention Type: PROCEDURE

Patients will undergo laparoscopic splenectomy through a single incision

Laparoscopic Splenectomy

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

Group Type: ACTIVE_COMPARATOR

Laparoscopic Splenectomy

Intervention Type: PROCEDURE

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

Interventions

Single Incision Splenectomy

Patients will undergo laparoscopic splenectomy through a single incision

Intervention Type: PROCEDURE

Laparoscopic Splenectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

SILS; Standard

Eligibility Criteria

Inclusion Criteria

• Need for splenectomy

Exclusion Criteria

• Splenomegaly

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Shawn St. Peter

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

09 09 196

Identifier Type: -

Identifier Source: org_study_id