Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
NCT Number: NCT07395505
The purpose of this study is to evaluate the feasibility of a standardized surgical and care process for patients with locally advanced or recurrent rectal cancer that has spread to nearby pelvic organs. When cancer invades adjacent structures (such as the sacrum, bladder, or prostate), a complex procedure called pelvic exenteration (PE) is often required to remove the tumor entirely.
This research does not involve testing new or experimental surgical techniques. All procedures performed in this study are part of standard clinical practice. Instead, the focus of this project is to:
Standardize Procedures: Create consistent, high-quality steps for the surgical team to follow.
Improve Teamwork: Enhance coordination between different medical specialists (such as colorectal surgeons, urologists, and oncologists) to provide better care.
Track Outcomes: Use a patient registry to monitor clinical data and quality of life after surgery through patient-reported surveys.
A total of 24 adult patients will be enrolled over a three-year period. By refining these workflows and monitoring patient recovery, the study aims to ensure that these complex surgeries are performed as safely and effectively as possible.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Taoyuan, 33305, Taiwan
This prospective, single-center surgical feasibility study is designed to establish and validate standardized protocols for patients undergoing pelvic exenteration (PE), with or without sacrectomy, for locally advanced or recurrent rectal cancer invading adjacent pelvic structures.
The study focuses on three primary operational pillars:
Precise identification and preservation of pelvic nerves.
Intraoperative assessment of sacrectomy levels (specifically targeting S2-S4).
Standardization of urological procedures and advanced reconstructive approaches for the pelvic floor.
Implementation and practical validation of Standard Operating Procedures (SOPs) to achieve consistent R0 resection margins.
As a feasibility study, the enrollment of 24 patients over three years will serve as a pilot to confirm the practicality of these SOPs and the efficiency of the MDT workflow in a high-complexity surgical setting. All procedures fall within the scope of standard clinical practice; the research focus remains on the optimization of care delivery and process standardization.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2026 to 2031
R0 resection rate
Time frame: 2026 to 2031
Major complication rate (Clavien-Dindo ≥ III)
Time frame: 2026 to 2031
Length of stay
Time frame: 2026 to 2031
readmission rate
Time frame: 2026 to 2031
90-day mortality
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031)
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life of cancer patients. Scores are transformed to a scale from 0 to 100. For the functional scales and global health status, higher scores represent a higher (better) level of functioning or quality of life. For the symptom scales, higher scores represent a higher (worse) level of symptoms.
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031)
This is a 29-item supplemental module specific to colorectal cancer. Scores range from 0 to 100. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate more severe symptoms.
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The IPSS consists of 7 questions regarding urinary symptoms and one quality of life question. The total symptom score ranges from 0 to 35. A higher total score indicates a worse outcome (more severe urinary symptoms).
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The ICIQ-UI SF is a 4-item questionnaire used to evaluate the frequency, severity, and impact of urinary incontinence. The total score ranges from 0 to 21. A higher score indicates a worse outcome (greater severity of urinary incontinence).
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The IIEF-5 is a 5-item questionnaire used to evaluate erectile function in male participants. The score ranges from 5 to 25. A higher score represents a better outcome (better erectile function).
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The FSFI is a 19-item questionnaire used to assess sexual function in female participants. The total score ranges from 2 to 36. A higher score represents a better outcome (better sexual function).
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The LARS score is used to assess bowel dysfunction after rectal surgery. The score ranges from 0 to 42. A higher score indicates a worse outcome (more severe bowel dysfunction).
Time frame: From recruitment to study completion (approximately 5 years, 2026-2031).
The Stoma-QoL is a 20-item questionnaire designed to measure quality of life in patients with a stoma. The total score is standardized to range from 0 to 100. A higher score represents a better outcome (better quality of life related to the stoma).
Chang Gung Memorial Hospital
Other
From Cure to Quality: Advancing Surgical and Postoperative Outcomes in Pelvic Exenteration
Acronym: PROS-PE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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