Incisional Hernia Clinical Trial
Official title:
Risk of Umbilical Trocar-site Hernia After SILC Versus Conventional Laparoscopic Cholecystectomy
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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