Clinical trial NCT01203566: A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
Official title: A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Appendicitis
Keywords: Single incision laparoscopic surgery
Single site access laparoscopic surgery
SILS
Single-port access
Laparoendoscopic single site surgery
Appendectomy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale
timeFrame: 1st post-operative day
Secondary outcomes:
measure: Conversion
timeFrame: 24 hours
measure: Operative time
timeFrame: 24 hours
measure: Wound infection
timeFrame: 14 days
measure: Deep space infection
timeFrame: 30 days
measure: activity score
timeFrame: 14 days
measure: Satisfaction score
timeFrame: 14 days
measure: Cosmesis score
timeFrame: 14 days
measure: quality of life
timeFrame: 14 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Deparment of Surgery, North District Hospital, Sheung Shui
city: Hong Kong
country: China
facility: Department of Surgery, Prince of Wales Hospital, Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Anthony Y Teoh, FRCSEd (Gen)
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1055/s-2002-36846.
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.
citation: 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.
citation: Teoh AY, Chiu PW, Wong TC, Poon MC, Wong SK, Leong HT, Lai PB, Ng EK. A double-blinded randomized controlled trial of laparoendoscopic single-site access versus conventional 3-port appendectomy. Ann Surg. 2012 Dec;256(6):909-14. doi: 10.1097/SLA.0b013e3182765fcf.