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Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy (UMBI-SILS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01740973
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital

Brief Summary:

Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain, especially around the umbilical port is dominating the first postoperative week. Single Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative incisional pain and improve cosmetic results, but results are not convincing and the risk of formation of an umbilical trocar-site hernia is not properly investigated.

This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy.

Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia).

The H0 hypothesis is that there is not difference between SILC and conventional.

Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.

Condition or disease
Cholecystolithiasis Incisional Hernia

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Study Type : Observational
Actual Enrollment : 699 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Umbilical Trocar-site Hernia After SILC Versus Conventional Laparoscopic Cholecystectomy
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

SILC cholecystectomy
No intervention. 239 SILC having a prospective questionnaire and clinical follow-up, if the patient suspects an umbilical hernia.
and conventional lap. cholecystectomy
no intervention.Patients are also mailed a prospective questionnaire and clinical follow-up, if the patient suspects an umbilical hernia.

Primary Outcome Measures :
  1. Umbilical trocar-site hernia formation [ Time Frame: participants will be followed for expected average of 3 years ]
    Operation for an umbilical trocar-site hernia or clinical trocar-site hernia formation

Secondary Outcome Measures :
  1. chronic pain and discomfort [ Time Frame: participants will be followed for expected average of 3 years ]
    The degree of long-term chronic pain and discomfort after cholecystectomy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient having a SILC in Denmark from 1/1-2009-1/6-2011 and matched conventional lap. cholecystectomies. Matched in gender, age, surgeons ecxperience

Inclusion Criteria:

  • SILC 1/1-2009-1/6-2011 and matched controls consecutively from the cholecystectomy-database having a lap. chol. one month before and one month after the SILC group.

Exclusion Criteria:

  • death in the follow-up time
  • an abdominal operation before la.chol/SILC with midline incision
  • an abdominal operation after la.chol/SILC with midline incision
  • primary operation for acute cholecystitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01740973

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Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Mette w Christoffersen Hvidovre University Hospital
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Responsible Party: Mette Willaume Christoffersen, M. D., Hvidovre University Hospital Identifier: NCT01740973    
Other Study ID Numbers: UMBI-SILS-123
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by Mette Willaume Christoffersen, Hvidovre University Hospital:
lap. cholecystectomy
trocar-site hernia
Additional relevant MeSH terms:
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Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases