Prospective Randomized Comparison of Clinical Results of Hand Assisted Laparoscopic Splenectomies and Open Splenectomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754806
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : September 18, 2008
Information provided by:
Istanbul University

Brief Summary:


Background: Although there are some comparative studies between laparoscopy and hand-assisted laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in splenomegaly cases.

Methods: This prospective study included 27 patients undergoing splenectomy for splenic disorders at the Department of General Surgery, Istanbul Medical Faculty between February 2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other 13 patients.

Key words: HALS, open splenectomy, splenomegaly

Condition or disease
Postoperative Pain

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 27 participants
Time Perspective: Prospective
Official Title: Prospective Randomized Study Between Open and Hand Assisted Splenectomies
Study Start Date : February 2007
Primary Completion Date : October 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spleen Diseases
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with splenomegaly who will have splenectomy procedures either open or HALS

Inclusion Criteria:

  • Splenomegaly 15 cm or longer spleens
  • Patient confirmation to join the study

Exclusion Criteria:

  • Normal sized spleens
  • Patient denial

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 identifier (NCT number): NCT00754806

Sponsors and Collaborators
Istanbul University
Principal Investigator: UMUT BARBAROS, ASSIST.PROF Istanbul Fcaulty of Medicine

Responsible Party: Istanbul Faculty of Medicine, Department of General Surgery Identifier: NCT00754806     History of Changes
Other Study ID Numbers: 1687-2007
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: September 18, 2008
Last Verified: September 2008

Keywords provided by Istanbul University:
open splenectomy
HALS as a hybrid approach of pure laparoscopy and open surgery has some definite advantages over open surgery
In the HALS group, incision length is significantly shorter
In the HALS group, postoperative pain is less than with open surgery
In the HALS group, postoperative hospital stay is shorter than with open surgery

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms