Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwok-Kay Yau, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT01024439
First received: November 30, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Acute Appendicitis
Procedure: transumbilical single incision laparoscopic appendicectomy
Procedure: conventional laparoscopic appendicectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Transumbilical Single Incision Laparoscopic Appendicectomy

Resource links provided by NLM:


Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

Primary Outcome Measures:
  • wound infection rate [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cosmetic satisfaction [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be at least 18 years of age.
  • Male or female (excluding pregnant females).
  • Patients with ASA ≦ 3.
  • Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations.

Exclusion Criteria:

  • Patients have previous history of abdominal surgery.
  • Patients with ASA > 3.
  • Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
  • Patients who are incompetent in giving consent.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01024439

Locations
China, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong, China, 852
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
  More Information

No publications provided

Responsible Party: Kwok-Kay Yau, Specialist in general surgery, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier: NCT01024439     History of Changes
Other Study ID Numbers: HKEC-2009-080
Study First Received: November 30, 2009
Last Updated: February 11, 2014
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014