Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00019217

Trial Description

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Title

Prospective observation study endoscopic evaluation of colorectal anastomoses

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In patients with a resection of the rectum we conduct a endoscopic examination of the connection on the 5.-8. day after the operation.

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Brief Summary in Scientific Language

We conduct an endoscopic control of the colorectal anastomosis after resection of the colon sigmoideum or rectum. The healing of the anastomosis will be graded with an endoscopic score.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019217
  •   2020/03/05
  •   [---]*
  •   yes
  •   Approved
  •   565/2017BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
  •   K57.20 -  [generalization K57.2: Diverticular disease of large intestine with perforation and abscess]
  •   K51.0 -  Ulcerative (chronic) pancolitis
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Interventions/Observational Groups

  •   Patients that underwent a colorectal resection with creation of a colorectal anastomosis, with or without loop Ileoostomy that matched the inclusion criteria received a flexible rectoscopy on day 5.-8. after Surgery as a screening. The anastomosis receives a rating via a sore. A possibly following therapeutic intervention wasn't part of this Study.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

successful and safe execution of an postoperative endoscopic Control of the anastomosis after a colorectal resection

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Secondary Outcome

- examination of anastomotic healing in regard to the different types of anastomis
examination of anastomotic healing related to the operation
- clinical relevance of an occult anastomotic leakage
- identification of clinical parameters enabling a prediction of the risk of an anstomotic leakage
- identification of criteria for the best timing of the operation
- application of a standardized score for the endoscopic evaluation of colorectal anastomosis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/03/22
  •   89
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Colorectal resection with creation of an anastomosis

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Exclusion Criteria

underage, inability for informed consent, postoperative intense care treatment and consecutive impossibility of endoscopy

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.