Condition category
Surgery
Date applied
13/01/2009
Date assigned
27/02/2009
Last edited
21/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jeffrey Marks

ORCID ID

Contact details

11100 Euclid Avenue
Mail Stop 5047
Cleveland
44106
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00832767

Protocol/serial number

AS08012

Study information

Scientific title

Prospective randomised controlled trial of traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy

Acronym

SILS™ Port Laparoscopic Cholecystectomy Study

Study hypothesis

The objectives of this trial are: 1) to assess the feasibility and safety of performing SILS™ port cholecystectomy, and 2) to monitor and compare the outcomes of SILS™ port cholecystectomy versus 4PLC to objectively document the scientific merit, and the perceived advantages of SILS™ port cholecystectomy.

Ethics approval

Italy: Ethics Committee, Universita Cattolica del Sacro Cuore, approved on 02/12/2008 (ref: Prot.cm.P822 [A.1505]/C.E./2008)
UK: To be submitted to Ethics Committee, Imperial College London, St Mary's Hospital, in January 2009.
USA: University Hospital Case Medical Center, Institutional Review Board for Human Investigations. Approval pending as of 13/01/2009.

Study design

Randomised controlled single-blind multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute calculus, acalculous cholecystitis

Intervention

Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy

Intervention type

Procedure/Surgery

Phase

Phase IV

Drug names

Primary outcome measures

1. Feasibility and safety of SILS™ port cholecystectomy versus four-port traditional laparoscopic cholecystectomy as indicated by intraoperative and postoperative adverse events up to one year
2. Operative time
3. Blood loss

Secondary outcome measures

1. Pain, assessed by the Pain Intensity numerical rating scale at 8 different timepoints within the first month post surgery
2. Cosmesis, assessed at 5 different timepoints between 1 week and 1 year post surgery by the following:
2.1. Modified Hollander scale
2.2. Body image questionnaire
2.3. Photo series questionnaire
3. Quality of life, assessed by the SF-8® and SF-12® Health Survey questionnaires at 7 different timepoints, once prior to surgery and 6 times up to 1 month post surgery
4. Time to return to normal activity
5. Time required for insertion of SILS™ Port compared to 4 standard ports

Overall trial start date

03/02/2009

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, between 18 and 65 years old
2. The patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or biliary dyskinesia with documented ejection fraction (EF) <30%
3. Body mass index (BMI) <35 kg/m^2
4. The patient or patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site
5. The patient agrees to return to the same research facility for all study-required post-procedure follow-up visits

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Any female patient who is pregnant, suspected pregnant, or nursing
2. Any patient with acute calculus or acalculous cholecystitis
3. Any patient who has had an upper midline or right sub costal incision
4. Any patient with pre-operative indication for a cholangiogram
5. Any patient with American Society of Anesthesiologists (ASA) >3 with normal liver function
6. Any patient who is undergoing peritoneal dialysis (PD)
7. Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair

Recruitment start date

03/02/2009

Recruitment end date

01/02/2011

Locations

Countries of recruitment

Italy, United Kingdom, United States of America

Trial participating centre

11100 Euclid Avenue
Cleveland
44106
United States of America

Sponsor information

Organisation

Covidien Surgical Devices (USA)

Sponsor details

c/o Donna Biracree
60 Middletown Avenue
North Haven
06473
United States of America

Sponsor type

Industry

Website

http://www.covidien.com

Funders

Funder type

Industry

Funder name

Covidien Surgical Devices (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23619321

Publication citations

  1. Results

    Marks JM, Phillips MS, Tacchino R, Roberts K, Onders R, DeNoto G, Gecelter G, Rubach E, Rivas H, Islam A, Soper N, Paraskeva P, Rosemurgy A, Ross S, Shah S, Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy., J. Am. Coll. Surg., 2013, 216, 6, 1037-47; discussion 1047-8, doi: 10.1016/j.jamcollsurg.2013.02.024.

Additional files

Editorial Notes