NCT00997516

Brief Summary

Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recovery, less pain, and fewer wound complications. The term SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field closer to surgery that is bloodless, incisionless, and painless. Despite the hype, prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS procedures have generally been limited to case reports and small case series that lack controls. The investigators propose to conduct a prospective, randomized, single-center trial of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute appendicitis. Primary end-points are operative time, complication rate, postoperative pain, recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS appendectomy is equivalent to laparoscopic appendectomy with respect to operative time, complication rate, postoperative pain, and recovery time while providing a better cosmetic outcome.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 22, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

October 15, 2009

Results QC Date

August 6, 2014

Last Update Submit

August 6, 2014

Conditions

Appendicitis

Keywords

LaparoscopyAppendicitisSingle-incision laparoscopic surgerySILS

Outcome Measures

Primary Outcomes (1)

  • Pain After Surgery

    Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.

    12 hours post-surgery

Secondary Outcomes (11)

  • Operative Time

    up to 6 hours

  • Procedures Requiring Conversion to Open or Additional Port

    during surgery , up to 6 hours

  • Visceral or Vascular Injury

    during surgery, up to 6 hours

  • Length of Stay

    up to 14 days

  • Wound Infection

    6 months

  • +6 more secondary outcomes

Study Arms (2)

SILS appendectomy

EXPERIMENTAL

The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis.

Procedure: SILS appendectomy

Conventional laparoscopic appendectomy

ACTIVE COMPARATOR

The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis.

Procedure: conventional laparoscopic appendectomy

Interventions

SILS appendectomyPROCEDURE

Use of SILSPort to perform laparoscopic appendectomy

SILS appendectomy
conventional laparoscopic appendectomyPROCEDURE

conventional laparoscopic removal of the appendix

Conventional laparoscopic appendectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Suspected acute appendicitis on clinical and radiographic (CT) grounds

You may not qualify if:

  • Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis
  • Prior open laparotomy with incision through the umbilicus
  • Body Mass Index \> 35
  • Age \<18 years
  • Mental illness, dementia, or inability to provide informed consent
  • Chronic pain requiring daily medication (including opiate and NSAIDs)
  • Pregnancy
  • Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (6)

  • Palanivelu C, Rajan PS, Rangarajan M, Parthasarathi R, Senthilnathan P, Praveenraj P. Transumbilical endoscopic appendectomy in humans: on the road to NOTES: a prospective study. J Laparoendosc Adv Surg Tech A. 2008 Aug;18(4):579-82. doi: 10.1089/lap.2007.0174.

    PMID: 18721008BACKGROUND

  • Chouillard K FA. Single incision appendectomy for acute appendicitis: a preliminary experience. In: SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only); 2009.

    BACKGROUND

  • Kravetz AJ ID, Kia MA. Initial experience in single-port laparoscopic appendectomies. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only)

    BACKGROUND

  • Nguyen NT, Reavis KM, Hinojosa MW, Smith BR, Stamos MJ. A single-port technique for laparoscopic extended stapled appendectomy. Surg Innov. 2009 Mar;16(1):78-81. doi: 10.1177/1553350608330528. Epub 2009 Jan 13.

    PMID: 19141492RESULT

  • Edwards C BA. Single incision laparoscopic appendectomy is safe and results in excellent cosmetic outcomes. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only) 2009.

    RESULT

  • Carter JT, Kaplan JA, Nguyen JN, Lin MY, Rogers SJ, Harris HW. A prospective, randomized controlled trial of single-incision laparoscopic vs conventional 3-port laparoscopic appendectomy for treatment of acute appendicitis. J Am Coll Surg. 2014 May;218(5):950-9. doi: 10.1016/j.jamcollsurg.2013.12.052. Epub 2014 Feb 19.

    PMID: 24684867DERIVED

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Results Point of Contact

Title
Jonathan T. Carter, MD, FACS
Organization
University of California, San Francisco
jonathan.carter@ucsfmedctr.org
415-476-0974

Study Officials

  • Jonathan T. Carter, M.D.

    UCSF Department of Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 19, 2009

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2014

Last Updated

August 22, 2014

Results First Posted

August 22, 2014

Record last verified: 2014-08

Locations

US(2)