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

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Cholecystitis
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Brief Title

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

Official Title

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

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.

Study Type

Observational

Primary Outcome

Umbilical trocar-site hernia formation

Secondary Outcome

 chronic pain and discomfort

Condition

Cholecystolithiasis

Study Arms / Comparison Groups

 SILC cholecystectomy
Description:  No intervention. 239 SILC having a prospective questionnaire and clinical follow-up, if the patient suspects an umbilical hernia.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

699

Start Date

April 2014

Completion Date

September 2014

Primary Completion Date

September 2014

Eligibility 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

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Mette w Christoffersen, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT01740973

Organization ID

UMBI-SILS-123

Responsible Party

Principal Investigator

Study Sponsor

Hvidovre University Hospital

Study Sponsor

Mette w Christoffersen, Principal Investigator, Hvidovre University Hospital

Verification Date

February 2015