Postoperative Results and Outcomes in Surgical Pelvic Exenteration

NCT07395505 | Enrolling By Invitation DMC

• 1 other identifier: 202501190A3C5001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Rectal Cancer Recurrent; Pelvic Exenteration; Advanced Rectal Cancer

Keywords

Advanced rectal cancer; Recurrent rectal cancer; Pelvic exenteration; Sacrectomy

Outcome Measures

Primary Outcomes (2)

• Short-term outcome

  R0 resection rate

  2026 to 2031

• Short-term outcome

  Major complication rate (Clavien-Dindo ≥ III)

  2026 to 2031

Secondary Outcomes (3)

• Short-term outcome

  2026 to 2031

• Short-term outcome

  2026 to 2031

• Short-term outcome

  2026 to 2031

Other Outcomes (8)

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

  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)

  From recruitment to study completion (approximately 5 years, 2026-2031)

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

  From recruitment to study completion (approximately 5 years, 2026-2031).

Study Arms (1)

Pelvic Exenteration Group

Adult patients with locally advanced or recurrent rectal adenocarcinoma invading adjacent organs undergo pelvic exenteration under a standardized multidisciplinary surgical protocol.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 40180681 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2025-11

Locations

TW (1)