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The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal resection | Procedure | Open or minimally invasive rectal resection with total mesorectal excision |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pelvic function before and after rectal resection | Rectal and urogenital function will be assessed preoperatively and 12-24 months and 5 years postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function). | 5 years |
| Rectal sphincter function before and after rectal resection | Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively | 5 years |
| Assessment of stool continence before and after rectal resection | Stool continence will be assessed preoperatively and 12-24 months and 5 years postoperatively using the LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse stool continence). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time [min] | Time from skin incision until placement of last skin staple/suture. | during surgery |
| Intraoperative blood loss [mL] | Intraoperative blood loss presents the amount of blood lost from skin incision until skin closure. Spilling water and ascites will be subtracted. Swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing rectal resection with total mesorectal excision
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Fritzmann, Dr. | Contact | +49 351 458 19477 | johannes.fritzmann@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Fritzmann, Dr. | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
Following publication of study results, de-identified patient data will be made available upon reasonable request
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| ID | Term |
|---|---|
| D000078542 | Proctectomy |
| ID | Term |
|---|---|
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| during surgery |
| Duration of postoperative hospital stay [days] | Postoperative day 1 until day of discharge | At day of discharge, assessed up to 90 days |
| Duration of postoperative intermediate/intensive care unit stay [days] | Postoperative day 1 until day of discharge | At day of discharge, assessed up to 90 days |
| Frequency of peri-operative morbidity after resection | Frequency of peri-operative complications after resection | 90 days after surgery |
| Kind of peri-operative morbidity after resection | Kind of peri-operative complications after resection | 90 days after surgery |
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