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

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00754806
First received: September 17, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

ABSTRACT

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
Postoperative Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Randomized Study Between Open and Hand Assisted Splenectomies

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Enrollment: 27
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with splenomegaly who will have splenectomy procedures either open or HALS

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Normal sized spleens
  • Patient denial
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00754806

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

No publications provided

Responsible Party: Istanbul Faculty of Medicine, Department of General Surgery
ClinicalTrials.gov Identifier: NCT00754806     History of Changes
Other Study ID Numbers: 1687-2007
Study First Received: September 17, 2008
Last Updated: September 17, 2008
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
HALS
open splenectomy
splenomegaly
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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014