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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing rectal resection with total mesorectal excision

Disqualifiers

primary or secondary removal of rectal sphincter apparatus

patients with enterostomy persisting 12 months after initial rectal resection

Trial population

All patients undergoing rectal resection with total mesorectal excision

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rectal resection

    Procedure/Surgery

    Open or minimally invasive rectal resection with total mesorectal excision

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
5 years
2

Rectal sphincter function before and after rectal resection

Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively

Time frame
5 years
3

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).

Time frame
5 years

Secondary outcomes

1

Operating time [min]

Time from skin incision until placement of last skin staple/suture.

Time frame
during surgery
2

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

Time frame
during surgery
3

Duration of postoperative hospital stay [days]

Postoperative day 1 until day of discharge

Time frame
At day of discharge, assessed up to 90 days
4

Duration of postoperative intermediate/intensive care unit stay [days]

Postoperative day 1 until day of discharge

Time frame
At day of discharge, assessed up to 90 days

Other outcomes

Sponsors and contacts

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