Status:
COMPLETED
A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Appendicitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 pai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01203566
Start Date
October 1 2009
End Date
April 1 2011
Last Update
July 21 2011
Active Locations (2)
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1
Deparment of Surgery, North District Hospital, Sheung Shui
Hong Kong, China
2
Department of Surgery, Prince of Wales Hospital, Shatin
Hong Kong, China