跳至主要内容
临床试验/NCT00754806
NCT00754806已完成不适用

Prospective Randomized Study Between Open and Hand Assisted Splenectomies

Istanbul University0 个研究点目标入组 27 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27

研究概览

简要总结

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

详细描述

The advent of laparoscopic surgery, increasing experience in its performance and advances in techniques and surgical devices have all greatly influenced general surgery. The usefulness of laparoscopic surgery has already been well proven in cholecystectomy, esophageal antireflux surgery, and splenectomy for benign diseases (1). Laparoscopy is also now gaining recognition for procedures accompanied by lymph node dissection, such as gastric and colorectal surgery (2, 3). The development of hand-assisted laparoscopic surgery (HALS) has also brought about improvements in regard to various disadvantages that have previously been associated with laparoscopic surgery, including lack of tactile sensation feedback, poor depth perception, lack of quick access in the event of unexpected hemorrhage, and difficulties with intracorporal suturing. Such improvements have enabled the performance of advanced laparoscopic surgery (4).

To solve the problems associated with a long learning curve and long operating times, hand ports have been introduced. Through the hand port, the surgeon's hand can be introduced into the abdomen while the pneumoperitoneum is preserved. The use of a hand port reduces operating time and shortens the learning curve (5). It has already been suggested that procedures requiring an incision to remove a specimen or organ are most suitable for HALS (6).

Laparoscopic splenectomy (LS) for the normal-sized spleen has been shown to be a safe procedure, resulting in short hospital stays, low postoperative pain scores, technical hurdles and, as a result, can be more difficult. LS has advantages over open splenectomy (7), and it is now considered by many surgeons to be the procedure of choice for normal-sized spleens. Splenectomy for giant spleens using solely laparoscopic approaches is feasible, but it can be time consuming and challenging to any surgeon despite his or her high level of experience with laparoscopy.

With increased splenic sizes, LS becomes more technically challenging, although the procedure is still feasible (8,5). Hand-assisted laparoscopic technique allows the surgeon to place one hand into the abdominal cavity while maintaining the pneumoperitoneum, recovering tactile sense and improving the accuracy of manipulation. This has been verified in various complicated laparoscopic procedures, including colectomies, nephrectomies, and hepatectomies. Based on these experiences, HALS may be well suited for the removal of splenomegaly when the final spleen weight is greater than 500 g (9).

It would be of interest to assess whether outcomes of the HALS hybrid technique approximate those obtained with laparoscopy or with the open approach. Since comparative studies between laparoscopy and HALS have been already carried out, we compared open splenectomy with HALS for splenomegaly cases. To our knowledge, this is the first prospective study to compare the results of HALS and OS.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Normal sized spleens
  • Patient denial

研究者

申办方类型
Other

相似试验

Prospective Randomized Comparison of Clinical... | 临床试验