A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

Phase 3CompletedNCT01203566

Chinese University of Hong Kong200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Appendicitis

Interventions

LESS appendectomyPROCEDURE

See under arms description

Conventional 3-port laparoscopic appendectomyPROCEDURE

See under arms description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Deparment of Surgery, North District Hospital, Sheung Shui

Hong Kong, China

Department of Surgery, Prince of Wales Hospital, Shatin

Hong Kong, China

Outcomes

Primary Outcomes

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

Time frame: 1st post-operative day

Secondary Outcomes

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

Time frame: 24 hours

Operative time

defined as the amount of time to perform the operation from skin-incision to application of the dressing.

Time frame: 24 hours

Wound infection

defined as presence of skin erythema, discharge and a positive culture

Time frame: 14 days

Deep space infection

defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.

Time frame: 30 days

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 \[1. no difficulty; 2. a little difficult; 3. some difficulty; 4. a lot of difficulty; 5. not able to perform.\]

Time frame: 14 days

Satisfaction score

Overall satisfaction of the procedure by the patient measured with the visual analogue scale

Data from ClinicalTrials.gov

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