NCT07395505Enrolling by invitation
Postoperative Results and Outcomes in Surgical Pelvic Exenteration
From Cure to Quality: Advancing Surgical and Postoperative Outcomes in Pelvic Exenteration
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 25 Jan 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07395505
What you commit to
- Study type: Observational
- Planned participants: 24
- From 1 Nov 2025 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe comorbidities rendering major surgery or anesthesia unsafe.
Other illness
- Unresectable disease or widespread distant metastasis.
Other
- Patients unable to complete postoperative follow-up or unwilling to participate in PROMs assessment.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.