A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01203566
First received: September 15, 2010
Last updated: July 19, 2011
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Appendicitis
Procedure: LESS appendectomy
Procedure: Conventional 3-port laparoscopic appendectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale [ Time Frame: 1st post-operative day ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Conversion [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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

  • Operative time [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    defined as the amount of time to perform the operation from skin-incision to application of the dressing.

  • Wound infection [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    defined as presence of skin erythema, discharge and a positive culture

  • Deep space infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.

  • activity score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.]

  • Satisfaction score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Overall satisfaction of the procedure by the patient measured with the visual analogue scale

  • Cosmesis score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    defined as the score given by the patient on the overall cosmesis of the wound measured by the visual analogue scale

  • quality of life [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up


Enrollment: 200
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional 3-port laparoscopic appendectomy
Laparoscopic appendectomy will be performed with the standard 3-port technique. The laparoscope is introduced via a 10mm subumbilical port. Dissection will be performed with a 5mm LLQ port and a 5mm RLQ port. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene.
Procedure: Conventional 3-port laparoscopic appendectomy
See under arms description
Active Comparator: LESS appendectomy
Two 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. Retraction of the appendix would be performed with a flexible curved forceps. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene.
Procedure: LESS appendectomy
See under arms description

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01203566

Locations
China
Department of Surgery, Prince of Wales Hospital, Shatin
Hong Kong, China
Deparment of Surgery, North District Hospital, Sheung Shui
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Anthony Y Teoh, FRCSEd (Gen) Chinese University of Hong Kong
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony Yuen Bun Teoh, Department of Surgery, Chinese University of Hong Kong, Hong Kong
ClinicalTrials.gov Identifier: NCT01203566     History of Changes
Other Study ID Numbers: CREC 2009.347
Study First Received: September 15, 2010
Last Updated: July 19, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Single incision laparoscopic surgery
Single site access laparoscopic surgery
SILS
Single-port access
Laparoendoscopic single site surgery
Appendectomy

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014