The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery

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.

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.

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.

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.

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.

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.

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.

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.

The observation window was defined as the period from the randomization date to the time of tumor recurrence in the patient, or death from any cause (whichever occurred first), or the last confirmed date of no recurrence and no death (censored date), with a follow-up period of 3 years after randomization.

The endpoint event was tumor recurrence in patients or death due to tumor recurrence. It refers to the time from the randomization date until the occurrence of tumor recurrence or death caused by tumor recurrence. Lost to follow-up during the follow-up period and deaths due to non-tumor recurrence causes were treated as censored values.

The endpoint event was patient death from any cause. The time from the randomization date to patient death from any cause was calculated. Lost-to-follow-up during follow-up was treated as censored.