Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy

NCT01024439 | Completed

• 1 other identifier: HKEC-2009-080
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• wound infection rate

  2 weeks after surgery

Secondary Outcomes (1)

• cosmetic satisfaction

  2 weeks after surgery

Study Arms (2)

single port

ACTIVE COMPARATOR

Patients will undergo transumbilical single incision laparoscopic appendicectomy.

Procedure: transumbilical single incision laparoscopic appendicectomy

conventional Lap

ACTIVE COMPARATOR

Patients will undergo conventional laparoscopic appendicectomy.

Procedure: conventional laparoscopic appendicectomy

Interventions

transumbilical single incision laparoscopic appendicectomy PROCEDURE

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.

single port

conventional laparoscopic appendicectomy PROCEDURE

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.

conventional Lap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong, 852, China

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in general surgery

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

CN (1)