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Patients are currently being operated in the robot instead due to logistics
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All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.
Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.
The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.
It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic total mesorectal excision | Patients operated with laparoscopic total mesorectal surgery for rectal cancer | ||
| transanal total mesorectal excision | Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of specimens with grade I specimen according to Quirke | Comparison with control group | 4 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | day of surgery | |
| Re-admission | 30 days | |
| Postoperative complications scored according to Clavien-Dindo within the first 12 months |
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Inclusion Criteria:
Exclusion Criteria:
-Participation in other trials in conflict with the protocol and end-points the LATA-trial
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Rectal cancer possible to operate with an anterior resection.
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| Name | Affiliation | Role |
|---|---|---|
| Eva Angenete, M.D., Ph.D. | Sahlgrenska Universitetssjukhuset/Östra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Surgery, Sahlgrenska University Hospital/Ostra | Gothenburg | SE 416 85 | Sweden | |||
| NU-sjukvården |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 12 months |
| Trollhättan |
| Sweden |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |