NCT06662643Active, not recruiting
A Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
This study targets patients undergoing ultra-low rectal cancer surgery, which requires internal sphincter resection for sphincter-saving procedures. The study compares the staged Turnbull-Cutait Pull-through anastomosis (a delayed transanal pull-through anastomosis without a protective stoma) as the experimental group with traditional anastomosis (hand-sewn/stapled) plus protective ileostomy as the control group. The aim is to assess whether the Turnbull-Cutait Pull-through colon-anal anastomosis is non-inferior to traditional ISR surgery in terms of complications (short-term such as anastomotic leakage/dehiscence, pelvic infection, anastomotic bleeding, ischemic bowel necrosis, bowel obstruction, and long-term complications such as anastomotic stricture, perianastomotic fistula, bowel obstruction, stoma-related complications, and others), postoperative anal function, quality of life, long-term oncologic outcomes, hospital stay duration, and total hospitalization costs.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 22 Oct 2024
- Start date
- 8 May 2024
- Primary completion date
- 30 May 2026
- Lead sponsor
- Zhongnan Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06662643
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 8 May 2024 to the primary completion date, 30 May 2026
- 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
- Previous colorectal or anorectal surgeries or diseases.
- Tumor invasion into the external sphincter, levator ani, or adjacent organs requiring combined organ resection.
- Participation in other clinical trials within the 4 weeks prior to enrollment.
Other illness
- History of malignant colorectal tumors.
- Patients requiring emergency surgery due to intestinal obstruction, perforation, or bleeding.
- History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP).
- Recent diagnosis of other malignancies.
- Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction or serious underlying disease precluding surgery.
- History of severe mental illness.
- Uncontrolled preoperative infection.
Lab values
- Other clinical or laboratory findings making the patient unsuitable for the study, as judged by the investigator.
Other
- Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).
- ASA classification ≥ IV or ECOG performance status ≥ 2.
- Pregnant or breastfeeding women.
Who the study is looking for
- Histopathologically confirmed high- or moderate-grade adenocarcinoma or villous adenoma with malignancy on preoperative colonoscopy; tumor located ≤ 5 cm from the anal verge; primary tumor size \< 5 cm in diameter.
- All enrolled patients require intersphincteric dissection. PISR surgery must be completed with hand-sewn (preferably) or stapled coloanal anastomosis. The anastomosis should be located near the dentate line (intraoperative photos or videos must be preserved).
- Both male and female patients aged 18-75.
- Non-recurrent rectal cancer.
- No concurrent multiple primary colorectal cancers.
- Initial staging or post-neoadjuvant therapy stage: T3 above the levator ani, T1-2 below.
- Liver or lung oligometastases deemed resectable after evaluation by a multidisciplinary team (MDT).
- Patients may or may not have received neoadjuvant chemoradiotherapy.
- Patients and families must understand and be willing to participate in this study, providing written informed consent.
- Good anal function (Wexner incontinence score ≤ 5).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.