Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

• Sponsor: Cantonal Hosptal, Baselland (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02500992
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

Study Description

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	Phase
Diverticular Disease	Procedure: Transrectal sigmoidectomy

Study Design

• Study Type: Observational
• Anticipated 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: Jul 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Transrectal sigmoidectomy Patients undergoing transrectal NOTES sigmoidectomy	Procedure: Transrectal sigmoidectomy
Laparoscopic-assisted sigmoidectomy Patients undergoing laparoscopic-assisted sigmoidectomy

Outcome Measures

Primary Outcome Measures

1. Peritoneal bacterial contamination [during surgery]

   microbacteriological swabs

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

Secondary Outcome Measures

1. septic complications [within 30 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Baselland Bruderholz	Bruderholz		Switzerland	4101

Sponsors and Collaborators

• Cantonal Hosptal, Baselland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Steinemann, MD, Consultant, Cantonal Hosptal, Baselland
• ClinicalTrials.gov Identifier: NCT02500992
• Other Study ID Numbers: NoBakt transrectal
• First Posted: Jul 17, 2015
• Last Update Posted: Jul 17, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Diverticular Diseases; Diverticulum

Study Results

No Results Posted as of Jul 17, 2015