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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01740973
First received: November 28, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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
Cholecystolithiasis
Incisional Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Umbilical Trocar-site Hernia After SILC Versus Conventional Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Umbilical trocar-site hernia formation [ Time Frame: participants will be followed for expected average of 3 years ] [ Designated as safety issue: No ]
    Operation for an umbilical trocar-site hernia or clinical trocar-site hernia formation


Secondary Outcome Measures:
  • chronic pain and discomfort [ Time Frame: participants will be followed for expected average of 3 years ] [ Designated as safety issue: No ]
    The degree of long-term chronic pain and discomfort after cholecystectomy


Estimated Enrollment: 700
Study Start Date: April 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740973

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Mette w Christoffersen Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Mette Willaume Christoffersen, M. D., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01740973     History of Changes
Other Study ID Numbers: UMBI-SILS-123
Study First Received: November 28, 2012
Last Updated: April 24, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
SILC
lap. cholecystectomy
trocar-site hernia

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Hernia
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014