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Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

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ClinicalTrials.gov Identifier: NCT02500992
Recruitment Status : Unknown
Verified July 2015 by Daniel Steinemann, MD, Cantonal Hosptal, Baselland.
Recruitment status was:  Recruiting
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland

Brief Summary:

Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.

Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.

In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.


Condition or disease Intervention/treatment
Diverticular Disease Procedure: Transrectal sigmoidectomy

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Transrectal sigmoidectomy
Patients undergoing transrectal NOTES sigmoidectomy
Procedure: Transrectal sigmoidectomy
Laparoscopic-assisted sigmoidectomy
Patients undergoing laparoscopic-assisted sigmoidectomy



Primary Outcome Measures :
  1. Peritoneal bacterial contamination [ Time Frame: during surgery ]
    microbacteriological swabs

  2. Contamination in the rectal stump after wash-out [ Time Frame: during surgery ]

Secondary Outcome Measures :
  1. septic complications [ Time Frame: within 30 days after surgery ]

Biospecimen Retention:   Samples Without DNA
Microbacteriological swabs


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.
Criteria

Inclusion Criteria:

  • Status post several episodes of diverticulitis
  • Status post contained diverticulitis

Exclusion Criteria:

  • not able to give informed consent
  • <18 years of age
  • pregnancy
  • emergency operation
  • acute diverticulitis

Information from the National Library of Medicine

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): NCT02500992


Contacts
Contact: Daniel C Steinemann, MD 41 61 436 27 04 daniel.steinemann@ksbl.ch

Locations
Switzerland
Kantonsspital Baselland Bruderholz Recruiting
Bruderholz, Switzerland, 4101
Contact: Daniel C Steinemann, MD       daniel.steinemann@ksbl.ch   
Contact: Sebastian Lamm, MD       sebastian.lamm@ksbl.ch   
Principal Investigator: Sebastian Lamm, MD         
Principal Investigator: Daniel C Steinemann, MD         
Principal Investigator: Andreas Zerz, MD         
Sponsors and Collaborators
Cantonal Hosptal, Baselland

Responsible Party: Daniel Steinemann, MD, Consultant, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT02500992     History of Changes
Other Study ID Numbers: NoBakt transrectal
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Diverticulum
Pathological Conditions, Anatomical