Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision (TaLaR03)
10. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
216
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Liang Kang, MD
- Telefonnummer: +8613602886833
- E-post: kangl@mail.sysu.edu.cn
Studer Kontakt Backup
- Navn: Ling Shuang Luo, MD
- Telefonnummer: +8613751756175
- E-post: kangl@mail.sysu.edu.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510655
- Rekruttering
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Intraoperative Conversion Rate
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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3-year disease-free survival (DFS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Liang Kang, Sixth Affiliated Hospital, Sun Yat-sen University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. juni 2025
Primær fullføring (Antatt)
28. april 2027
Studiet fullført (Antatt)
28. april 2029
Datoer for studieregistrering
Først innsendt
24. mai 2026
Først innsendt som oppfylte QC-kriteriene
10. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025ZSLYEC-104
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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