Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision (TaLaR03)
10. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
216
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Liang Kang, MD
- Telefonnummer: +8613602886833
- E-Mail: kangl@mail.sysu.edu.cn
Studieren Sie die Kontaktsicherung
- Name: Ling Shuang Luo, MD
- Telefonnummer: +8613751756175
- E-Mail: kangl@mail.sysu.edu.cn
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510655
- Rekrutierung
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Intraoperative Conversion Rate
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3-year disease-free survival (DFS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Liang Kang, Sixth Affiliated Hospital, Sun Yat-sen University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. Juni 2025
Primärer Abschluss (Geschätzt)
28. April 2027
Studienabschluss (Geschätzt)
28. April 2029
Studienanmeldedaten
Zuerst eingereicht
24. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Juni 2026
Zuerst gepostet (Tatsächlich)
16. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025ZSLYEC-104
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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