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Enrolling by Invitation

NCT Number: NCT07395505

Postoperative Results and Outcomes in Surgical Pelvic Exenteration

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.

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Key information

About this study

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:

  • Standardization of Surgical Techniques and SOPs The project aims to refine and standardize complex surgical maneuvers to ensure technical consistency across cases. This includes:

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.

  • Prospective Data Integration and Quality of Life Monitoring A systematic case registry will be established to capture comprehensive perioperative clinical data. Beyond clinical metrics, the study integrates Patient-Reported Outcome Measures (PROMs) to evaluate the impact of PE on long-term postoperative function and quality of life. This data will be used to optimize clinical workflows and improve patient counseling regarding functional recovery.
  • Multidisciplinary Team (MDT) Synergy The study reinforces a collaborative care model involving colorectal surgery, urology, orthopedics, oncology, radiology, and pathology. By strengthening MDT collaboration, the project aims to enhance perioperative care quality, from preoperative surgical candidacy review to postoperative management.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged ≥20 years.
  • Histologically confirmed rectal adenocarcinoma or anal adenocarcinoma.
  • Tumor invasion of sacrum (requiring sacrectomy, S2-S4) or anterior structures (e.g., prostate), or lateral structures(SLAM, vessels, nerve) where resection of the invaded organ is necessary to achieve R0 resection, as determined by MDT.
  • Surgical candidacy confirmed by multidisciplinary review (colorectal surgery, urology, orthopedics, oncology, radiology, pathology).
  • Preoperative imaging (MRI, PET/CT) confirming resectable disease without distant metastasis.
  • Signed informed consent obtained.

Exclusion criteria

  • Unresectable disease or widespread distant metastasis.
  • Severe comorbidities rendering major surgery or anesthesia unsafe.
  • Patients unable to complete postoperative follow-up or unwilling to participate in PROMs assessment.

Treatment and study plan

Primary outcomes

  1. Short-term outcome

    Time frame: 2026 to 2031

    R0 resection rate

  2. Short-term outcome

    Time frame: 2026 to 2031

    Major complication rate (Clavien-Dindo ≥ III)

Secondary outcomes

  1. Short-term outcome

    Time frame: 2026 to 2031

    Length of stay

  2. Short-term outcome

    Time frame: 2026 to 2031

    readmission rate

  3. Short-term outcome

    Time frame: 2026 to 2031

    90-day mortality

Other outcomes

  1. PROMs:Quality of Life Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    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.

  2. PROMs:Quality of Life Measured by EORTC Quality of Life Questionnaire Colorectal Cancer Module (QLQ-CR29)

    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.

  3. PROMs:Urinary Function Measured by International Prostate Symptom Score (IPSS)

    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).

  4. PROMs:Urinary Incontinence Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    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).

  5. PROMs:Male Sexual Function Measured by International Index of Erectile Function (IIEF-5)

    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).

  6. PROMs:Female Sexual Function Measured by Female Sexual Function Index (FSFI)

    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).

  7. PROMs:Bowel Function Measured by Low Anterior Resection Syndrome (LARS) Score

    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).

  8. PROMs:Stoma-Related Quality of Life Measured by Stoma Quality of Life (Stoma-QoL) Questionnaire

    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).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

From Cure to Quality: Advancing Surgical and Postoperative Outcomes in Pelvic Exenteration

Acronym: PROS-PE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

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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