Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy (UMBI-SILS)
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|ClinicalTrials.gov Identifier: NCT01740973|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 12, 2015
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|
|Study Type :||Observational|
|Actual Enrollment :||699 participants|
|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|
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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01740973
|Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Mette w Christoffersen||Hvidovre University Hospital|