Rectal Surgery
Conditions
Brief summary
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.
Interventions
PROCEDURERectal resection
Open or minimally invasive rectal resection with total mesorectal excision
Sponsors
Technische Universität Dresden
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing rectal resection with total mesorectal excision
Exclusion criteria
* primary or secondary removal of rectal sphincter apparatus * patients with enterostomy persisting 12 months after initial rectal resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of stool continence before and after rectal resection | 5 years | 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). |
| Assessment of pelvic function before and after rectal resection | 5 years | 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). |
| Rectal sphincter function before and after rectal resection | 5 years | Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative hospital stay [days] | At day of discharge, assessed up to 90 days | Postoperative day 1 until day of discharge |
| Duration of postoperative intermediate/intensive care unit stay [days] | At day of discharge, assessed up to 90 days | Postoperative day 1 until day of discharge |
| Kind of peri-operative morbidity after resection | 90 days after surgery | Kind of peri-operative complications after resection |
| Frequency of peri-operative morbidity after resection | 90 days after surgery | Frequency of peri-operative complications after resection |
| Operating time [min] | during surgery | Time from skin incision until placement of last skin staple/suture. |
| Intraoperative blood loss [mL] | during surgery | 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 |
Countries
Germany
Contacts
CONTACTJohannes Fritzmann, Dr.
PRINCIPAL_INVESTIGATORJohannes Fritzmann, Dr.
Technische Universität Dresden
Outcome results
None listed