Clinical trial · Observational
Postoperative Results and Outcomes in Surgical Pelvic Exenteration
From Cure to Quality: Advancing Surgical and Postoperative Outcomes in Pelvic Exenteration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Pelvic Exenteration | — | UNRESOLVED | — |
| Rectal Cancer Recurrent | Rectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Pelvic Exenteration Group
- description
- Adult patients with locally advanced or recurrent rectal adenocarcinoma invading adjacent organs undergo pelvic exenteration under a standardized multidisciplinary surgical protocol.
Primary outcomes (2)
- measure
- Short-term outcome
- timeFrame
- 2026 to 2031
- description
- R0 resection rate
- measure
- Short-term outcome
- timeFrame
- 2026 to 2031
- description
- Major complication rate (Clavien-Dindo ≥ III)
Secondary outcomes (3)
- measure
- Short-term outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHsu 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. PMID 40180681