Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

• Conditions: Diverticular Disease
• Interventions: Procedure: Transrectal sigmoidectomy

• Registration Number: NCT02500992
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transrectal sigmoidectomy	Transrectal sigmoidectomy	Patients undergoing transrectal NOTES sigmoidectomy

Primary Outcome Measures

Name	Time	Method
Peritoneal bacterial contamination	during surgery	microbacteriological swabs
Contamination in the rectal stump after wash-out	during surgery

Secondary Outcome Measures

Name	Time	Method
septic complications	within 30 days after surgery

Trial Locations

Locations (1)

Kantonsspital Baselland Bruderholz; 🇨🇭 Bruderholz, Switzerland