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

Официальное название

The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery: A Multicenter Randomized Controlled Trial (FIAS)

Обзор

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.

Вмешательства

• Процедура Turnbull-Cutait anastomosis
  First 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
• Процедура LAR
  First 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

Первичные конечные точки

• 3-year stoma-free survival postoperatively [Срок оценки: 3 years]

Вторичные конечные точки (3)

• LARS grading [Срок оценки: 3 months, 6 months, 9 months, 1 year, 2 years, 3 years]
• Wexner scale [Срок оценки: 3 months, 6 months, 9 months, 1 year, 2 years, 3 years]
• Quality of Life Questionnaire (EORTC QLQ-CR29) [Срок оценки: 1 month, 6 months, 1 year]

Критерии участия

Критерии включения

• 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;
• Preoperative BMI < 28 kg/m²
• Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• First Hospital of Jilin University — Changchun
• First Hospital of Jilin University — Changchun

Публикации

• Yamada K, Ogata S, Saiki Y, Fukunaga M, Tsuji Y, Takano M. Functional results of intersphincteric resection for low rectal cancer. Br J Surg. 2007 Oct;94(10):1272-7. doi: 10.1002/bjs.5534. PMID 17671960
• Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont PMID 32172199
• David GG, Slavin JP, Willmott S, Corless DJ, Khan AU, Selvasekar CR. Loop ileostomy following anterior resection: is it really temporary? Colorectal Dis. 2010 May;12(5):428-32. doi: 10.1111/j.1463-1318.2009.01815.x. Epub 2009 Feb 17. PMID 19226365
• Lindgren R, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. What is the risk for a permanent stoma after low anterior resection of the rectum for cancer? A six-year follow-up of a multicenter trial. Dis Colon Rectum. 2011 Jan;54(1):41-7. doi: 10.1007/DCR.0b013e3181fd2948. PMID 21160312
• Bailey CM, Wheeler JM, Birks M, Farouk R. The incidence and causes of permanent stoma after anterior resection. Colorectal Dis. 2003 Jul;5(4):331-4. doi: 10.1046/j.1463-1318.4.s1.1_78.x. PMID 12814411
• den Dulk M, Smit M, Peeters KC, Kranenbarg EM, Rutten HJ, Wiggers T, Putter H, van de Velde CJ; Dutch Colorectal Cancer Group. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol. 2007 Apr;8(4):297-303. doi: 10.1016/S1470-2045(07)70047-5. PMID 17395102
• Dinnewitzer A, Jager T, Nawara C, Buchner S, Wolfgang H, Ofner D. Cumulative incidence of permanent stoma after sphincter preserving low anterior resection of mid and low rectal cancer. Dis Colon Rectum. 2013 Oct;56(10):1134-42. doi: 10.1097/DCR.0b013e31829ef472. PMID 24022530
• Jorgensen JB, Erichsen R, Pedersen BG, Laurberg S, Iversen LH. Stoma reversal after intended restorative rectal cancer resection in Denmark: nationwide population-based study. BJS Open. 2020 Oct 6;4(6):1162-71. doi: 10.1002/bjs5.50340. Online ahead of print. PMID 33022143

Идентификаторы

NCT: NCT07369531 · FIAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗