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Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

C

Cantonal Hosptal, Baselland

Status

Unknown

Conditions

Diverticular Disease

Treatments

Procedure: Transrectal sigmoidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT02500992
NoBakt transrectal

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Transrectal sigmoidectomy
Description:
Patients undergoing transrectal NOTES sigmoidectomy
Treatment:
Procedure: Transrectal sigmoidectomy
Laparoscopic-assisted sigmoidectomy
Description:
Patients undergoing laparoscopic-assisted sigmoidectomy

Trial contacts and locations

1

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Central trial contact

Daniel C Steinemann, MD

Data sourced from clinicaltrials.gov

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