A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

Appendicitis Clinical Trial

Official title:

A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203566
• Other study ID #: CREC 2009.347
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2010
• Last updated: July 19, 2011
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy.

Description:

Since the original description in the 1970's, the laparoscopic approach to management of surgical diseases has gained widespread acceptance. It has been shown to be associated with decreased wound pain, analgesic requirements, hospital stay and allows improved cosmesis and quality of life without significantly increasing the risks of morbidities and mortalities. With continued improvements in technology, however, efforts to reduce the number of abdomen wounds in an attempt to further decrease pain, improve cosmesis and outcomes are underway. Natural Orifices Transluminal Endoscopic Surgery (NOTES) has received widespread attention in both the medical field as well as the general public. However, there are still a multitude of problems that needs to be solved before the technique can be broadly applied to human subjects [7]. On the other hand, a renewed interest in single incision laparoscopic surgeries is emerging. The approach has been shown to be safe and feasible in our experience as well as the others. It also has the potential to further decrease the surgical trauma induced to the patient and to improve cosmesis.

Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic surgery, it is an appropriate model for initial evaluation of single incision laparoscopic surgery. Our unit has already performed 20 cases of single site access laparoscopic appendicectomy (SSALA) and so far, the results have been encouraging (data pending publication). All the patients in the series had their procedures completed with a single incision. None of the patients suffered from adverse events and all had resumption of oral diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is more beneficial as compared to conventional three-port laparoscopic appendicectomy is still uncertain.

Hence, the aim of the current study is to compare the approach of SSALA to conventional three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant

• Fever = 38°C and/or WCC > 10 X 103 cells per mL,

• Right lower quadrant guarding, and tenderness on physical examination.

• All patients included were 18-75 years old.

Exclusion Criteria:

• Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable to urinary or gynaecological problems).

• History of symptoms > 5 days and/or a palpable mass in the right lower quadrant, suggesting an appendiceal abscess treated with antibiotics and possible percutaneous drainage.

• Patients with the following conditions are also excluded: history of cirrhosis and coagulation disorders, generalized peritonitis, shock on admission, previous abdominal surgery, ascites, suspected or proven malignancy, contraindication to general anesthesia (severe cardiac and/or pulmonary disease), inability to give informed consent due to mental disability, and pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• LESS appendectomy
See under arms description
• Conventional 3-port laparoscopic appendectomy
See under arms description

Locations

Country	Name	City	State
China	Deparment of Surgery, North District Hospital, Sheung Shui	Hong Kong
China	Department of Surgery, Prince of Wales Hospital, Shatin	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (3)

Chow A, Purkayastha S, Paraskeva P. Appendicectomy and cholecystectomy using single-incision laparoscopic surgery (SILS): the first UK experience. Surg Innov. 2009 Sep;16(3):211-7. doi: 10.1177/1553350609344413. Epub 2009 Aug 31. — View Citation

Hong TH, Kim HL, Lee YS, Kim JJ, Lee KH, You YK, Oh SJ, Park SM. Transumbilical single-port laparoscopic appendectomy (TUSPLA): scarless intracorporeal appendectomy. J Laparoendosc Adv Surg Tech A. 2009 Feb;19(1):75-8. doi: 10.1089/lap.2008.0338. — View Citation

Pappalepore N, Tursini S, Marino N, Lisi G, Lelli Chiesa P. Transumbilical laparoscopic-assisted appendectomy (TULAA): a safe and useful alternative for uncomplicated appendicitis. Eur J Pediatr Surg. 2002 Dec;12(6):383-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale	The main outcome is the overall pain score (measured as the most severe pain experienced within the last 24 hrs using the visual analogue scale) experienced by the patient after the operation	1st post-operative day	No
Secondary	Conversion	defined by the use of incisions and/or trocars in addition to the ones described in the Methods section, or the need to perform an open procedure	24 hours	Yes
Secondary	Operative time	defined as the amount of time to perform the operation from skin-incision to application of the dressing.	24 hours	Yes
Secondary	Wound infection	defined as presence of skin erythema, discharge and a positive culture	14 days	Yes
Secondary	Deep space infection	defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.	30 days	Yes
Secondary	activity score	defined by a composite score including 4 items using a five point scale: lying in bed, getting out of chair or bed, walking on level ground and climbing stairs [1. no difficulty; 2. a little difficult; 3. some difficulty; 4. a lot of difficulty; 5. not able to perform.]	14 days	No
Secondary	Satisfaction score	Overall satisfaction of the procedure by the patient measured with the visual analogue scale	14 days	No
Secondary	Cosmesis score	defined as the score given by the patient on the overall cosmesis of the wound measured by the visual analogue scale	14 days	No
Secondary	quality of life	measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up	14 days	No