Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

July 16, 2015 updated by: Daniel Steinemann, MD, Cantonal Hosptal, Baselland

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bruderholz, Switzerland, 4101
        • Recruiting
        • Kantonsspital Baselland Bruderholz
        • Principal Investigator:
          • Daniel C Steinemann, MD
        • Principal Investigator:
          • Sebastian Lamm, MD
        • Principal Investigator:
          • Andreas Zerz, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritoneal bacterial contamination
Time Frame: during surgery
microbacteriological swabs
during surgery
Contamination in the rectal stump after wash-out
Time Frame: during surgery
during surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
septic complications
Time Frame: within 30 days after surgery
within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hosptal, Baselland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NoBakt transrectal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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