Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

Diverticular Disease Clinical Trial

Official title:

Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500992
• Other study ID #: NoBakt transrectal
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 16, 2015
• Start date: July 2015

Study information

• Verified date: July 2015
• Source: Cantonal Hosptal, Baselland
• Contact: Daniel C Steinemann, MD
• Phone: 41 61 436 27 04
• Email: daniel.steinemann[@]ksbl.ch
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diverticular Disease
• Diverticulum

Intervention

Procedure:
• Transrectal sigmoidectomy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland Bruderholz	Bruderholz

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal bacterial contamination	microbacteriological swabs	during surgery	No
Primary	Contamination in the rectal stump after wash-out		during surgery	No
Secondary	septic complications		within 30 days after surgery	Yes