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

NCT05257746 | Recruiting

• 1 other identifier: VTG-10
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Operating time [min]

  during surgery

• Intraoperative blood loss [mL]

  during surgery

• Duration of postoperative hospital stay [days]

  At day of discharge, assessed up to 90 days

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

  At day of discharge, assessed up to 90 days

• Frequency of peri-operative morbidity after resection

  90 days after surgery

Interventions

Rectal resection PROCEDURE

Open or minimally invasive rectal resection with total mesorectal excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing rectal resection with total mesorectal excision

You may qualify if:

• Patients undergoing rectal resection with total mesorectal excision

You may not qualify if:

• primary or secondary removal of rectal sphincter apparatus
• patients with enterostomy persisting 12 months after initial rectal resection

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Interventions

Proctectomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Johannes Fritzmann, Dr.

  Technical University Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Fritzmann, Dr.

CONTACT

+49 351 458 19477; johannes.fritzmann@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 25, 2022
• Study Start: March 3, 2021
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)