NCT02500992

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 15, 2015

Last Update Submit

July 16, 2015

Conditions

Diverticular Disease

Outcome Measures

Primary Outcomes (2)

  • Peritoneal bacterial contamination

    microbacteriological swabs

    during surgery

  • Contamination in the rectal stump after wash-out

    during surgery

Secondary Outcomes (1)

  • septic complications

    within 30 days after surgery

Study Arms (2)

Transrectal sigmoidectomy

Patients undergoing transrectal NOTES sigmoidectomy

Procedure: Transrectal sigmoidectomy

Laparoscopic-assisted sigmoidectomy

Patients undergoing laparoscopic-assisted sigmoidectomy

Interventions

Transrectal sigmoidectomyPROCEDURE
Transrectal sigmoidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.

You may qualify if:

  • Status post several episodes of diverticulitis
  • Status post contained diverticulitis

You may not qualify if:

  • not able to give informed consent
  • \<18 years of age
  • pregnancy
  • emergency operation
  • acute diverticulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland Bruderholz

Bruderholz, 4101, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbacteriological swabs

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Daniel C Steinemann, MD

CONTACT

41 61 436 27 04daniel.steinemann@ksbl.ch

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 17, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

CH(1)