Transanal Stapled Anastomosis
Conditions
Brief summary
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.
Interventions
DEVICETransanal stapling device
Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna * Ability and willingness to understand and comply with study interventions and restrictions. * Voluntarily signed informed consent after full explanation of the study to the participant.
Exclusion criteria
* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives * Inability to communicate well with the investigator due to language problems or reduced mental development * Inability or unwillingness to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EAUS | 3 months postoperative | Change in thickness of the anal sphincter muscles in mm from baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoanal manometry | 3 months postoperative | Change in Anal pressure in mmHg from baseline to 3 months |
| EAUS2 | 3 months postoperative | Change in the defect grade of anal sphincter muscles from baseline to 3 months |
| EAUS2-2 | 12 months postoperative | Change in thickness of the anal sphincter muscles in mm from baseline to 12 months |
| Endoanal manometry2 | 12 months postoperative | Change in Anal pressure in mmHg from baseline to 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| LARS Score | 3 months postoperative | Change in LARS Score from baseline to 3 months |
| LARS Score2 | 12 months postoperative | Change in LARS Score from baseline to 12 months |
| LARS2 | 12 months postoperative | Change in LARS Score from baseline to 12 months |
| Vaizey Score | 3 months postoperative | Change in Vaizey Score from baseline to 3 months |
| Vaizey Score2 | 12 months postoperative | Change in Vaizey Score from baseline to 12 months |
Countries
Austria
Contacts
Primary ContactChristopher Dawoud, MD
Outcome results
None listed