Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Sep 2026
    • Enrollment target: estimated 1114 to confirmed 1115
    • Secondary endpoints: details revised at 2 of 9 entries
    • Site details revised at 16 of 16 sites
    • Collaborators: details revised at 2 of 15 entries
    • Publications: details revised at 5 of 5 entries
  2. Notable Primary and study completion dates: Jul 2025 to Jul 2026
    • Site details revised at 1 of 16 sites
    v13
  3. Minor Re-verified, no change to tracked fieldsv12
  4. Notable Primary completion date: Jul 2021 to Jul 2025
    • Eligibility criteria expanded, about 10 words
    • Study description expanded, about 34 words
    v11
  5. Notable Primary endpoints: 1 to 2
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description expanded, about 6 words
    v10
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  1. Minor Study sites: 13 to 16
    • Collaborators: 14 to 15
    v9
  2. Minor Primary completion date: Jan 2021 to Jul 2021
    • Study completion date: Jan 2025 to Jul 2025
    • Eligibility criteria shortened, about 6 words
    v8
  3. Minor Study sites: 14 to 13
    • Collaborators: 15 to 14
    v7
  4. Notable Primary completion date: Jan 2020 to Jan 2021
    • Study sites: 11 to 14
    • Collaborators: 11 to 15
    v6
  5. Minor Study sites: 8 to 11
    • Secondary endpoints: details revised at 4 of 9 entries
    • Collaborators: 9 to 11
    v5
  6. Minor Study sites: 1 to 8
    • Collaborators revised (9)
    v4
  7. Notable Phase: Phase 2/3 to Not applicablev3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2017 to Apr 2016
    • Secondary endpoints revised (9)
    • Site details revised
  8. Minor Secondary endpoints: details revised at 1 of 9 entries
    • Collaborators: 8 to 9
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called "down-to-up" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.
Trial Details
NCT Number NCT02966483
Lead Sponsor Sun Yat-sen University
Collaborators: Peking Union Medical College Hospital, The First Hospital of Jilin University, RenJi Hospital, Shengjing Hospital, The Second People's Hospital of Yibin, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Nanchong Central Hospital, Zunyi Medical College, The First Affiliated Hospital of University of South China, Xinqiao Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital Xi'an Jiaotong University, Ruijin Hospital, Affiliated Hospital of Guangdong Medical University, The Third Xiangya Hospital of Central South University
Conditions
(from sponsor)
Rectal Neoplasms Malignant, Surgery
Related terms Rectal Neoplasms
Enrollment 1,115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov