Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy

Incisional Hernia Clinical Trial

— UMBI-SILS  

Official title:

Risk of Umbilical Trocar-site Hernia After SILC Versus Conventional Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740973
• Other study ID #: UMBI-SILS-123
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: February 11, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical trocar-site hernia formation	Operation for an umbilical trocar-site hernia or clinical trocar-site hernia formation	participants will be followed for expected average of 3 years	No
Secondary	chronic pain and discomfort	The degree of long-term chronic pain and discomfort after cholecystectomy	participants will be followed for expected average of 3 years	No