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. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer? 2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery.
Participants will:
1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio. 2. Receive the corresponding surgical intervention. 3. Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery. 4. Provide relevant clinical data (perioperative, pathological, follow-up) as required.
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, and without invasion of the external anal sphincter;
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 received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below;
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;
Parallel
Turnbull-Cutait anastomosis
Procedure/SurgeryFirst Surgery 1. Abdominal procedure: The inferior mesenteric artery is ligated at its root. The splenic flexure of the colon is mobilized. 2. After mobilization to the levator ani hiatus and entry into the intersphincteric space, the procedure switches to transanal operation. The full thickness of the rectal wall is incised 1 cm above the lower edge of the tumor. 5. The rectal tumor and sigmoid colon are pulled out transanally. The sigmoid colon is transected approximately 8 cm above the tumor to complete tumor resection. The distal sigmoid colon is pulled out 4-5 cm through the anus, and the four pre-placed marking sutures are secured to fix sigmoid colon to the anal canal stump. Second Surgery 1. The second surgery for resecting the pulled-out intestinal segment is performed 7-11 days after the first operation. The pulled-out intestinal segment is transected approximately 2 mm caudal to the anal canal stump plane. Subsequently, end-to-end anastomosis is completed.
LAR
Procedure/SurgeryFirst Surgery 1. The inferior mesenteric artery is transected at its root. 2. After mobilization to the levator ani hiatus, surgeons may choose to transect the intestinal tract using a linear cutting stapler under laparoscopy according to the location of the tumor's lower margin. Subsequently, a circular stapler is inserted transanally to perform sigmoid-colorectal anastomosis or sigmoid-anal canal anastomosis. 3. If the tumor is adjacent to the anal canal, an intersphincteric resection (ISR) is required, and hand-sewn end-to-end sigmoid-anal canal anastomosis is completed transanally. 4. All patients in the LAR group undergo a protective stoma, which is placed in the right lower quadrant through the rectus abdominis muscle as a loop ileostomy. Second Surgery The stoma reversal surgery for patients in the LAR group should be completed 3 to 4 months after the first surgery.
3-year stoma-free survival postoperatively
The primary endpoint of the present study was 3-year stoma-free survival. An endpoint event was defined as all-cause mortality or the establishment of a permanent, non-reversible intestinal stoma, whichever occurred first within the follow-up period. A non-reversible stoma was stipulated as one that remained unclosed at the completion of the 3-year surveillance interval, at the time of loss to follow-up, or upon patient demise. Individuals who remained event-free but were censored owing to incomplete longitudinal ascertainment were incorporated as censored observations in the subsequent survival analytical paradigm.
LARS grading
The full name of LARS grading is Low Anterior Resection Syndrome grading, with its core assessment tool being the LARS score (Low Anterior Resection Syndrome score). This grading system categorizes patients into three levels based on the LARS score: no LARS (0-20 points), mild LARS (21-29 points), and severe LARS (30-42 points). It quantifies the severity of intestinal dysfunction following low anterior resection of the rectum, with higher scores indicating more severe dysfunction.
Wexner scale
The Wexner scale, formally known as the Wexner Fecal Incontinence Rating Scale, is a commonly used tool for quantitatively assessing the severity of anal incontinence. The scoring range is 0-20 points, with 0 indicating normal and 20 indicating complete incontinence. Higher scores indicate more severe incontinence.
Quality of Life Questionnaire (EORTC QLQ-CR29)
The EORTC QLQ-CR29, formally known as the European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire 29 Items, is used to assess health-related quality of life in colorectal cancer patients. The functional dimension score ranges from 0 to 100, with higher scores indicating better functional status. The symptom dimension score also ranges from 0 to 100, with higher scores indicating more severe symptoms.
Types and Classification of Postoperative Complications
Both surgical complications should be recorded separately, with documentation including the type and severity of complications. Types include infection (incisional infection, pulmonary infection, urinary tract infection, etc.), hemorrhage, organ dysfunction (e.g., cardiac insufficiency, respiratory failure, renal impairment, etc.), anastomotic leakage, thrombosis (deep vein thrombosis, pulmonary embolism, etc.), gastrointestinal dysfunction (e.g., intestinal obstruction, diarrhea, constipation, etc.), and other adverse events directly or indirectly related to the surgery. The severity of complications is typically assessed using the Clavien-Dindo classification system.
Surgical duration
The duration from the start of the procedure (e.g., skin incision) to the end of the procedure (e.g., completion of suture closure) is recorded in minutes.
Postoperative hospitalization duration
The postoperative hospitalization duration for both procedures shall be recorded separately. The number of days a patient is hospitalized after surgery is calculated from the end of the procedure until discharge.
Hospitalization expenses
The hospitalization costs for both surgical procedures shall be recorded separately. All medical expenses incurred during the patient's hospitalization period (including the surgical and postoperative recovery phases) shall be documented, covering surgical fees, anesthesia fees, medication fees, examination and testing fees (such as laboratory tests, imaging examinations, etc.), nursing fees, bed fees, medical device usage fees (such as implants, disposable consumables, etc.), and other treatment-related expenses.
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The First Hospital of Jilin University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
