LESS appendectomy
ProcedureSee under arms description
NCT Number: NCT01203566
LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Deparment of Surgery, North District Hospital, Sheung Shui, Hong Kong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See under arms description
See under arms description
Time frame: 1st post-operative day
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
Time frame: 24 hours
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
Time frame: 24 hours
defined as the amount of time to perform the operation from skin-incision to application of the dressing.
Time frame: 14 days
defined as presence of skin erythema, discharge and a positive culture
Time frame: 30 days
defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.
Time frame: 14 days
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.]
Time frame: 14 days
Overall satisfaction of the procedure by the patient measured with the visual analogue scale
Time frame: 14 days
defined as the score given by the patient on the overall cosmesis of the wound measured by the visual analogue scale
Time frame: 14 days
measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up
Chinese University of Hong Kong
Other
A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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