Rectal Cancer RecurrentPROS-PENCT07395505
Postoperative Results and Outcomes in Surgical Pelvic Exenteration
An observational study of Rectal Cancer Recurrent and Pelvic Exenteration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Cancer Recurrent, Pelvic Exenteration, Advanced Rectal Cancer
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2025to 1 Feb 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
Read the 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:
- 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.
- Keywords
- Advanced rectal cancer, Recurrent rectal cancer, Pelvic exenteration, Sacrectomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome
R0 resection rate
Measured: 2026 to 2031
Short-term outcome
Major complication rate (Clavien-Dindo ≥ III)
Measured: 2026 to 2031
Secondary outcomes (3)
Short-term outcome
Length of stay
Measured: 2026 to 2031
Short-term outcome
readmission rate
Measured: 2026 to 2031
Short-term outcome
90-day mortality
Measured: 2026 to 2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Nov 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395505
- Sponsor's protocol ID
- 202501190A3C5001
- Acronym
- PROS-PE
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the corresponding author upon reasonable request
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.
PubMed 40180681
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Cure to Quality: Advancing Surgical and Postoperative Outcomes in Pelvic Exenteration
- ClinicalTrials.gov ID
- NCT07395505
- Acronym / sponsor ID
- PROS-PE / 202501190A3C5001
- Keywords
- Advanced rectal cancer, Recurrent rectal cancer, Pelvic exenteration, Sacrectomy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Exenteration Group | – | –Adult patients with locally advanced or recurrent rectal adenocarcinoma invading adjacent organs undergo pelvic exenteration under a standardized multidisciplinary surgical protocol. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term outcome
Time frame: 2026 to 2031
R0 resection rate
Short-term outcome
Time frame: 2026 to 2031
Major complication rate (Clavien-Dindo ≥ III)
3 secondary outcomes
Short-term outcome
Time frame: 2026 to 2031
Short-term outcome
Time frame: 2026 to 2031
Short-term outcome
Time frame: 2026 to 2031
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 40180681Hsu 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.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Recurrent and Pelvic Exenteration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term outcome (time frame: 2026 to 2031). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07395505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.