Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision (TaLaR03)
10 giugno 2026 aggiornato da: Yanhong Deng, Sun Yat-sen University
A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer
TME remains standard treatment for rectal cancer.
Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer.
To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population.
Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
Both RTME and taTME are innovative surgical techniques with potential advantages in low rectal cancer.
Intraoperative conversion rate is a key safety metric.
In low rectal cancer, changes in surgical approach not only affect resection outcomes but also sphincter preservation.To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population.
Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.
The primary indicator in this study is intraoperative conversion rate.
Definition in each group as follows: During transanal total mesorectal excision (taTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance.
During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance.
Tipo di studio
Interventistico
Iscrizione (Stimato)
216
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Liang Kang, MD
- Numero di telefono: +8613602886833
- Email: kangl@mail.sysu.edu.cn
Backup dei contatti dello studio
- Nome: Ling Shuang Luo, MD
- Numero di telefono: +8613751756175
- Email: kangl@mail.sysu.edu.cn
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina, 510655
- Reclutamento
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:Newly diagnosed patients aged 18-75 years. Pathologically confirmed adenocarcinoma (tubular, papillary, mucinous, or signet-ring). Tumor ≤7 cm from anal verge (MRI or DRE). Clinical stage T1-T3, N+, M0 (AJCC 8th ed.), suitable for sphincter-preserving TME. ASA score I-III.
ECOG performance status 0-1. Informed consent obtained.
- Exclusion Criteria: Synchronous/metachronous colorectal cancers, local recurrence, or distant metastases. Bowel obstruction, perforation, bleeding requiring emergency surgery. Involvement of sphincter or adjacent organs requiring Inter-sphincter Resection (ISR). Poor preoperative anal function/incontinence. IBD or familial adenomatous polyposis (FAP).
Pregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: robotic TME
For patients with low rectal cancer, the da Vinci multi-arm robotic system is used to perform total mesorectal excision (TME).
The procedure includes vascular ligation, mesenteric mobilization, distal bowel transection beyond the tumor, and anastomosis, all completed transabdominally with robotic assistance.
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This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)
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Sperimentale: taTME
For patients with low rectal cancer, a combined transanal and transabdominal approach is used to complete the total mesorectal excision (TME).
A purse-string suture is placed approximately 1 cm below the distal tumor margin, followed by insertion of a single-port device.
The mesorectum is then mobilized from bottom to top.
Vascular ligation is performed laparoscopically via the abdominal approach.
The two teams (transanal and transabdominal) meet near the peritoneal reflection.
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This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Intraoperative Conversion Rate
Lasso di tempo: at the end of operation
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During transanal total mesorectal excision (TaTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance. During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance. |
at the end of operation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-year disease-free survival (DFS)
Lasso di tempo: three years after the operation
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3-Year DFS (Disease-Free Survival) refers to the proportion of patients who remain alive and free from any signs or recurrence of the disease for three years following surgical removal of the primary tumor.
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three years after the operation
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3-Year OS
Lasso di tempo: 3 years after the operation
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3-Year OS (Overall Survival) refers to the percentage of patients who remain alive for three years following a surgical procedure, regardless of the cause of death or the status of the disease.
The survival time is typically calculated from the date of surgery to the date of death from any cause.
Patients who are alive at the three-year mark-whether they are disease-free, have experienced a recurrence, or are receiving other treatments-are counted as survivors
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3 years after the operation
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operative time
Lasso di tempo: 1 day after the operation
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Operative time refers to the total duration measured from the initial surgical incision to the completion of wound closure.
It typically includes all intraoperative procedures, such as dissection, resection (e.g., tumor removal), reconstruction, hemostasis, and placement of drains or implants, but excludes anesthesia induction, positioning, prepping, draping, and recovery room time
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1 day after the operation
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Liang Kang, Sixth Affiliated Hospital, Sun Yat-sen University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Liu H, Zeng Z, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Hao Y, Luo S, Zhang X, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Tong W, Ren M, Wang J, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial. Ann Surg. 2023 Jan 1;277(1):1-6. doi: 10.1097/SLA.0000000000005523. Epub 2022 Jul 11.
- Jiang W, Xu J, Cui M, Qiu H, Wang Z, Kang L, Deng H, Chen W, Zhang Q, Du X, Yang C, Guo Y, Zhong M, Ye K, You J, Xu D, Li X, Xiong Z, Tao K, Ding K, Zang W, Feng Y, Pan Z, Wu A, Huang F, Huang Y, Wei Y, Su X, Chi P; LASRE trial investigators. Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Jan;10(1):34-43. doi: 10.1016/S2468-1253(24)00273-5. Epub 2024 Nov 8.
- Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8.
- Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123.
- Zeng Z, Luo S, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Shi L, Ling L, Zhang X, Huang L, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Wang J, Tong W, Ren M, Liu H, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Mar 4;333(9):774-783. doi: 10.1001/jama.2024.24276.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 giugno 2025
Completamento primario (Stimato)
28 aprile 2027
Completamento dello studio (Stimato)
28 aprile 2029
Date di iscrizione allo studio
Primo inviato
24 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 giugno 2026
Primo Inserito (Effettivo)
16 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025ZSLYEC-104
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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