Postoperative Results and Outcomes in Surgical Pelvic Exenteration (PROS-PE)

From Cure to Quality: Advancing Surgical and Postoperative Outcomes in 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced Rectal Cancer; Rectal Cancer Recurrent; Pelvic Exenteration

Detailed Description

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:

1. 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.

2. 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.
3. 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.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan District, Taiwan, 33305
    • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age ≥ 20 years) with histologically confirmed locally advanced or recurrent rectal or anal adenocarcinoma invading adjacent pelvic structures (such as the sacrum, prostate, or bladder) who undergo pelvic exenteration (PE) with or without sacrectomy at Chang Gung Memorial Hospital during the three-year study period.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pelvic Exenteration Group; Adult patients with locally advanced or recurrent rectal adenocarcinoma invading adjacent organs undergo pelvic exenteration under a standardized multidisciplinary surgical protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term outcome	R0 resection rate	2026 to 2031
Short-term outcome	Major complication rate (Clavien-Dindo ≥ III)	2026 to 2031

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term outcome	Length of stay	2026 to 2031
Short-term outcome	readmission rate	2026 to 2031
Short-term outcome	90-day mortality	2026 to 2031

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMs：Quality of Life Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	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.	From recruitment to study completion (approximately 5 years, 2026-2031)
PROMs：Quality of Life Measured by EORTC Quality of Life Questionnaire Colorectal Cancer Module (QLQ-CR29)	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.	From recruitment to study completion (approximately 5 years, 2026-2031)
PROMs：Urinary Function Measured by International Prostate Symptom Score (IPSS)	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).	From recruitment to study completion (approximately 5 years, 2026-2031).
PROMs：Urinary Incontinence Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	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).	From recruitment to study completion (approximately 5 years, 2026-2031).
PROMs：Male Sexual Function Measured by International Index of Erectile Function (IIEF-5)	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).	From recruitment to study completion (approximately 5 years, 2026-2031).
PROMs：Female Sexual Function Measured by Female Sexual Function Index (FSFI)	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).	From recruitment to study completion (approximately 5 years, 2026-2031).
PROMs：Bowel Function Measured by Low Anterior Resection Syndrome (LARS) Score	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).	From recruitment to study completion (approximately 5 years, 2026-2031).
PROMs：Stoma-Related Quality of Life Measured by Stoma Quality of Life (Stoma-QoL) Questionnaire	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).	From recruitment to study completion (approximately 5 years, 2026-2031).

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Hsu YJ, Yu ZH, Jong BK, You JF, Yu YL, Liao CK, Lai CC, Chern YJ. Short- and long-term outcomes of minimally invasive vs. open pelvic exenteration in rectal tumours: a focused meta-analysis. Int J Colorectal Dis. 2025 Apr 3;40(1):86. doi: 10.1007/s00384-025-04876-z.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Advanced rectal cancer; Pelvic exenteration; Recurrent rectal cancer; Sacrectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 202501190A3C5001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No