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A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LESS appendectomy
Conventional 3-port laparoscopic appendectomy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Single incision laparoscopic surgery, Single site access laparoscopic surgery, SILS, Single-port access, Laparoendoscopic single site surgery, Appendectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Deparment of Surgery, North District Hospital, Sheung Shui
  • Department of Surgery, Prince of Wales Hospital, Shatin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional 3-port laparoscopic appendectomy

LESS appendectomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Operative time
defined as the amount of time to perform the operation from skin-incision to application of the dressing.
Wound infection
defined as presence of skin erythema, discharge and a positive culture
Deep space infection
defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.
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.]
Satisfaction score
Overall satisfaction of the procedure by the patient measured with the visual analogue scale
Cosmesis score
defined as the score given by the patient on the overall cosmesis of the wound measured by the visual analogue scale
quality of life
measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up

Full Information

First Posted
September 15, 2010
Last Updated
July 19, 2011
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01203566
Brief Title
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

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Single incision laparoscopic surgery, Single site access laparoscopic surgery, SILS, Single-port access, Laparoendoscopic single site surgery, Appendectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional 3-port laparoscopic appendectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LESS appendectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LESS appendectomy
Intervention Description
See under arms description
Intervention Type
Procedure
Intervention Name(s)
Conventional 3-port laparoscopic appendectomy
Intervention Description
See under arms description
Primary Outcome Measure Information:
Title
Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale
Description
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 Outcome Measure Information:
Title
Conversion
Description
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
Title
Operative time
Description
defined as the amount of time to perform the operation from skin-incision to application of the dressing.
Time Frame
24 hours
Title
Wound infection
Description
defined as presence of skin erythema, discharge and a positive culture
Time Frame
14 days
Title
Deep space infection
Description
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
Title
activity score
Description
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
Title
Satisfaction score
Description
Overall satisfaction of the procedure by the patient measured with the visual analogue scale
Time Frame
14 days
Title
Cosmesis score
Description
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
Title
quality of life
Description
measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Y Teoh, FRCSEd (Gen)
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deparment of Surgery, North District Hospital, Sheung Shui
City
Hong Kong
Country
China
Facility Name
Department of Surgery, Prince of Wales Hospital, Shatin
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
12548490
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.
Results Reference
background
PubMed Identifier
19196084
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.
Results Reference
background
PubMed Identifier
19723692
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.
Results Reference
background
PubMed Identifier
23154391
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.
Results Reference
derived

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A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

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