A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.

NCT01203566 | Completed Phase 3 DMC

• 1 other identifier: CREC 2009.347
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Appendicitis

Keywords

Single incision laparoscopic surgery; Single site access laparoscopic surgery; SILS; Single-port access; Laparoendoscopic single site surgery; Appendectomy

Outcome Measures

Primary Outcomes (1)

• 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

  1st post-operative day

Secondary Outcomes (8)

• Conversion

  24 hours

• Operative time

  24 hours

• Wound infection

  14 days

• Deep space infection

  30 days

• activity score

  14 days

Study Arms (2)

Conventional 3-port laparoscopic appendectomy

ACTIVE COMPARATOR

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

LESS appendectomy

ACTIVE COMPARATOR

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

Interventions

LESS appendectomy PROCEDURE

See under arms description

LESS appendectomy

Conventional 3-port laparoscopic appendectomy PROCEDURE

See under arms description

Conventional 3-port laparoscopic appendectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Deparment of Surgery, North District Hospital, Sheung Shui

Hong Kong, China

Location

Department of Surgery, Prince of Wales Hospital, Shatin

Hong Kong, China

Location

Related Publications (4)

• 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.

  PMID: 12548490 BACKGROUND

• 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.

  PMID: 19196084 BACKGROUND

• 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.

  PMID: 19723692 BACKGROUND

• 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.

  PMID: 23154391 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Anthony Y Teoh, FRCSEd (Gen)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2010-09

Locations

CN (2)