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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAR group | Active Comparator | First Surgery
Second Surgery The stoma reversal surgery for patients in the LAR group should be completed 3 to 6 months after the first surgery. |
|
| TCA group | Experimental | First Surgery
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 7-14 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turnbull-Cutait anastomosis | Procedure | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Wang Professor | Contact | +86 15843073207 | wquan@jlu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17671960 | Background | 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. | |
| 32172199 | Background | 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 A, Shi Q, Andre T; ACCENT Group. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12. |
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| LAR | Procedure | 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 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 months, 6 months, 9 months, 1 year, 2 years, 3 years |
| 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. | 3 months, 6 months, 9 months, 1 year, 2 years, 3 years |
| 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. | 1 month, 6 months, 1 year |
| 3 years |
| 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. | From the start of the procedure (e.g., skin incision) to the completion of the surgery (e.g., suturing the incision) |
| 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. | Perioperative |
| 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. | Perioperative |
| Three-year disease-free survival after surgery | 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. | 3 years |
| Recurrence rate at 3 years postoperatively | 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. | 3 years |
| Three-year overall survival after surgery | 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. | 3 years |
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
|
| 19226365 | Background | 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. |
| 21160312 | Background | 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. |
| 12814411 | Background | 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. |
| 17395102 | Background | 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. |
| 24022530 | Background | 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. |
| 33022143 | Background | 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. |
| 38016136 | Background | Xu X, Zhong H, You J, Ren M, Fingerhut A, Zheng M, Li J, Yang X, Song H, Zhang S, Ding C, Abuduaini N, Yu M, Liu J, Zhang Y, Kang L, Cai Z, Feng B. Revolutionizing sphincter preservation in ultra-low rectal cancer: exploring the potential of transanal endoscopic intersphincteric resection (taE-ISR): a propensity score-matched cohort study. Int J Surg. 2024 Feb 1;110(2):709-720. doi: 10.1097/JS9.0000000000000945. |
| 34508549 | Background | Back E, Haggstrom J, Holmgren K, Haapamaki MM, Matthiessen P, Rutegard J, Rutegard M. Permanent stoma rates after anterior resection for rectal cancer: risk prediction scoring using preoperative variables. Br J Surg. 2021 Nov 11;108(11):1388-1395. doi: 10.1093/bjs/znab260. |
| 32931137 | Background | Gadan S, Floodeen H, Lindgren R, Rutegard M, Matthiessen P. What is the risk of permanent stoma beyond 5 years after low anterior resection for rectal cancer? A 15-year follow-up of a randomized trial. Colorectal Dis. 2020 Dec;22(12):2098-2104. doi: 10.1111/codi.15364. Epub 2020 Oct 24. |
| 38985480 | Background | Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262. |
| 32492131 | Background | Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19. |
| 35344150 | Background | La Raja C, Foppa C, Maroli A, Kontovounisios C, Ben David N, Carvello M, Spinelli A. Surgical outcomes of Turnbull-Cutait delayed coloanal anastomosis with pull-through versus immediate coloanal anastomosis with diverting stoma after total mesorectal excision for low rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2022 Aug;26(8):603-613. doi: 10.1007/s10151-022-02601-4. Epub 2022 Mar 28. |
| 22442904 | Background | Beirens K, Penninckx F; PROCARE. Defunctioning stoma and anastomotic leak rate after total mesorectal excision with coloanal anastomosis in the context of PROCARE. Acta Chir Belg. 2012 Jan;112(1):10-4. doi: 10.1080/00015458.2012.11680789. |
| 38241345 | Background | Guo Y, He L, Tong W, Ren S, Chi Z, Tan K, Wang B, Lie C, Wang Q. Intersphincteric resection following robotic-assisted versus laparoscopy-assisted total mesorectal excision for middle and low rectal cancer: a multicentre propensity score analysis of 1571 patients. Int J Surg. 2024 Apr 1;110(4):1904-1912. doi: 10.1097/JS9.0000000000001053. |
| 7953423 | Background | Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg. 1994 Sep;81(9):1376-8. doi: 10.1002/bjs.1800810944. |
| 23575394 | Background | Rullier E, Denost Q, Vendrely V, Rullier A, Laurent C. Low rectal cancer: classification and standardization of surgery. Dis Colon Rectum. 2013 May;56(5):560-7. doi: 10.1097/DCR.0b013e31827c4a8c. |
| 4565861 | Background | Parks AG. Transanal technique in low rectal anastomosis. Proc R Soc Med. 1972 Nov;65(11):975-6. doi: 10.1177/003591577206501128. No abstract available. |
| 13882795 | Background | CUTAIT DE, FIGLIOLINI FJ. A new method of colorectal anastomosis in abdominoperineal resection. Dis Colon Rectum. 1961 Sep-Oct;4:335-42. doi: 10.1007/BF02627230. No abstract available. |
| 13778709 | Background | TURNBULL RB Jr, CUTHBERTSON A. Abdominorectal pull-through resection for cancer and for Hirschsprung's disease. Delayed posterior colorectal anastomosis. Cleve Clin Q. 1961 Apr;28:109-15. doi: 10.3949/ccjm.28.2.109. No abstract available. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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