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New treatment option for Rectal Cancer
Official title The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery
ClinicalTrials.gov ID: NCT07369531
What this study is testing
- What it's testing
- The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
- Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
- Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between...
- For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus...
- Preoperative BMI \< 28 kg/m²
You likely can't join if
- Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
- History of previous open surgery (non-minimally invasive procedures);
- Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor;
- Pregnant patients or those with concurrent inflammatory bowel disease;
- Preoperative patients with complete intestinal obstruction or requiring emergency surgery;
- Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.;
See the full eligibility criteria
- Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
- Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
- Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm...
- For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who...
- Preoperative BMI \< 28 kg/m²
- Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).
- Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
- History of previous open surgery (non-minimally invasive procedures);
- Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor;
- Pregnant patients or those with concurrent inflammatory bowel disease;
- Preoperative patients with complete intestinal obstruction or requiring emergency surgery;
- Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.;
- Recent treatment for other malignancies;
- Low rectal cancer classified as type IV in the Bordeaux classification system;
- Intraoperatively confirmed distant metastatic disease
- Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma. Withdrawal Criteria
- Patients who refuse surgical intervention after randomization.
- Patients who undergo an abdominoperineal resection (APR) following randomization.
- Patients who request voluntary withdrawal from the trial at any time throughout the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.