NCT00981136

Brief Summary

This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy. The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

September 21, 2009

Last Update Submit

February 13, 2013

Conditions

Appendicitis

Keywords

AppendicitisAppendectomyChildrenLaparoscopicSILS

Outcome Measures

Primary Outcomes (1)

  • Post-operative infection

    6 weeks

Secondary Outcomes (6)

  • Doses of analgesic

    3 days

  • Operative time

    1 day

  • Cosmetic scores

    6 months

  • Length of Hospitalization

    1 week

  • Surgeon perception of difficulty

    1 day

  • +1 more secondary outcomes

Study Arms (2)

SILS

ACTIVE COMPARATOR

Single Incision Laparoscopic Surgery (SILS) where a single incision in the umbilicus is all that is used to remove the appendix. The specific methods (staple/tie/port use/etc) will vary depending on surgeon.

Procedure: Single Incision Laparoscopic Appendectomy

3 port

ACTIVE COMPARATOR

Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.

Procedure: 3 port laparoscopic appendectomy

Interventions

Single Incision Laparoscopic AppendectomyPROCEDURE

A single incision through the umbilicus to remove the appendix

Also known as: SILS
SILS
3 port laparoscopic appendectomyPROCEDURE

Standard 3 port laparoscopic appendectomy with intracorporeal stapling

Also known as: Laparoscopic Appendectomy
3 port

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children under 18 years
  • Non-perforated appendicitis

You may not qualify if:

  • Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

  • St Peter SD, Shah SR, Adibe OO, Sharp SW, Reading B, Cully B, Holcomb GW 3rd, Rivard DC. Saline vs Tissue Plasminogen Activator Irrigations after Drain Placement for Appendicitis-Associated Abscess: A Prospective Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):390-6. doi: 10.1016/j.jamcollsurg.2015.03.043. Epub 2015 Mar 30.

    PMID: 26141467DERIVED

  • St Peter SD, Adibe OO, Iqbal CW, Fike FB, Sharp SW, Juang D, Lanning D, Murphy JP, Andrews WS, Sharp RJ, Snyder CL, Holcomb GW, Ostlie DJ. Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: a prospective randomized trial. Ann Surg. 2012 Oct;256(4):581-5. doi: 10.1097/SLA.0b013e31826a91e5.

    PMID: 22964730DERIVED

  • St Peter SD, Adibe OO, Juang D, Sharp SW, Garey CL, Laituri CA, Murphy JP, Andrews WS, Sharp RJ, Snyder CL, Holcomb GW 3rd, Ostlie DJ. Single incision versus standard 3-port laparoscopic appendectomy: a prospective randomized trial. Ann Surg. 2011 Oct;254(4):586-90. doi: 10.1097/SLA.0b013e31823003b5.

    PMID: 21946218DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Shawn d St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

December 1, 2011

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(1)