Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

NCT ID: NCT02500992

Last Updated: 2015-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Brief Summary

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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

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Conditions

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Diverticular Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Transrectal sigmoidectomy

Patients undergoing transrectal NOTES sigmoidectomy

Transrectal sigmoidectomy

Intervention Type PROCEDURE

Laparoscopic-assisted sigmoidectomy

Patients undergoing laparoscopic-assisted sigmoidectomy

No interventions assigned to this group

Interventions

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Transrectal sigmoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hosptal, Baselland

OTHER

Sponsor Role lead

Responsible Party

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Daniel Steinemann, MD

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kantonsspital Baselland Bruderholz

Bruderholz, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Daniel C Steinemann, MD

Role: CONTACT

41 61 436 27 04

Facility Contacts

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Daniel C Steinemann, MD

Role: primary

Sebastian Lamm, MD

Role: backup

Other Identifiers

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NoBakt transrectal

Identifier Type: -

Identifier Source: org_study_id

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