Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy
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|ClinicalTrials.gov Identifier: NCT01024439|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : February 12, 2014
Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital stay and less wound complications. Most of the time, three small wounds of less than 10mm will be adequate enough for the completion of the surgery with minimal pain.
Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to the attention of single incision laparoscopic surgery (SILS) again in the surgical community. SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et al. However, the close proximity of the instruments, limitation in triangulation during dissection and suboptimal exposure of the surgical field has made this approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has recently release their preliminary results on the use of SILS on appendicectomy with satisfactory results in terms of less post-operative pain and less prominent scar. However, it was a case series with limited number of patients. In order to test the advantages of SILS on the management of patients with acute appendicitis, a double blinded randomized clinical trial is conducted.
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis||Procedure: transumbilical single incision laparoscopic appendicectomy Procedure: conventional laparoscopic appendicectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Transumbilical Single Incision Laparoscopic Appendicectomy|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2013|
Active Comparator: single port
Patients will undergo transumbilical single incision laparoscopic appendicectomy.
Procedure: transumbilical single incision laparoscopic appendicectomy
Patients will undergo transumbilical single incision laparoscopic appendicectomy. A single incision is made on umbilicus within the margin of umbilical skin ring. Peritoneal cavity is entered by open method and the fascia layer can be extended up to 2.5cm in length. A single incision laparoscopic device (Olympus) will be inserted. Conventional laparoscopic instruments will be used. Umbilical fascia will be closed by PDS-1 J-shape needle. Marcain 0.5% should be infiltrated into the fascial layers as well as the skin layers with dosage up to 20ml. The umbilicus is reconstructed by interrupted 3-0 nylon by tacking the skin onto the fascia layers.
Three non-transparent dressings will be placed as if conventional laparoscopic appendicectomy has been done.
Active Comparator: conventional Lap
Patients will undergo conventional laparoscopic appendicectomy.
Procedure: conventional laparoscopic appendicectomy
Patients will undergo conventional laparoscopic appendicectomy. A 10-mm subumbilical port will be inserted by open method. Two 5-mm working ports will be inserted under laparoscopic view at patient's left lower quadrant and suprapubic area. Umbilical fascia will be closed by PDS-1 J-shape needle.
Local anaesthetic agent , Marcain 0.5% should be infiltrated into the fascial layers as well as the skin layers with dosage up to 20ml. All skin wound will be approximated with 3-0 nylon interrupted stitches and covered with non-transparent dressings.
- wound infection rate [ Time Frame: 2 weeks after surgery ]
- cosmetic satisfaction [ Time Frame: 2 weeks after surgery ]
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 ClinicalTrials.gov identifier (NCT number): NCT01024439
|China, Hong Kong|
|Pamela Youde Nethersole Eastern Hospital|
|Hong Kong, Hong Kong, China, 852|