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
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|
|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|
Patients undergoing transrectal NOTES sigmoidectomy
Procedure: Transrectal sigmoidectomy
Patients undergoing laparoscopic-assisted sigmoidectomy
- Peritoneal bacterial contamination [ Time Frame: during surgery ]microbacteriological swabs
- Contamination in the rectal stump after wash-out [ Time Frame: during surgery ]
- septic complications [ Time Frame: within 30 days after surgery ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Daniel C Steinemann, MD||41 61 436 27 email@example.com|
|Kantonsspital Baselland Bruderholz||Recruiting|
|Bruderholz, Switzerland, 4101|
|Contact: Daniel C Steinemann, MD firstname.lastname@example.org|
|Contact: Sebastian Lamm, MD email@example.com|
|Principal Investigator: Sebastian Lamm, MD|
|Principal Investigator: Daniel C Steinemann, MD|
|Principal Investigator: Andreas Zerz, MD|