Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection

Conditions
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Rectal Surgery

Intervention / Treatment
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* Procedure: Rectal resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Rectal resection|Open or minimally invasive rectal resection with total mesorectal excision|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |