Clinical trial · Interventional
The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer patients have been considerably improved. However, anatomical limitations in pelvic space hinder the further optimization of surgical treatment Thus, the natural orifice transluminal endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception and single port technique, has been prevailing both in West and East nations, with or without the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws in each instrument remains according to the feedbacks. This study is therefore designed to clinically evaluate the feasibility and safety of the new instruments specifically for TaTME (CS-Compact, GelPoint pathway).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TaTME with CS-Compact (GelPoint pathway) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TaTME with CS-Compact (GelPoint Path)
- description
- Based on newly-designed devices tailored for transanal TME, CS-Compact, GelPoint and Octoport are employed for the clinical applications.
- interventionNames
- Device: TaTME with CS-Compact (GelPoint pathway)
Primary outcomes (1)
- measure
- Number of participants with post-operative complications
- timeFrame
- postoperative 30days (hospital-stay time course)
- description
- Number of participants with post-operative complications (e.g. numbers of postoperative bleeding, leakage, infections)
Secondary outcomes (2)
- measure
- 3-year disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * rectal cancer patients, confirmed by the endoscopic biopsy; * curative rectal cancer in clinical stage with resectable lesion, the cTNM stage \<T3 stage, with comparable tumor size in low or medial rectum. * patients' general information, 18ys\<age\<75ys, no restriction in genders, BMI\< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification \<2 (Zubrod-ECOG-WHO) * patients or representatives have agreed and signed the informed consent documents. Exclusion Criteria: * have received neo-adjuvant chemotherapy or radiotherapy before operations; * previous surgery in pelvis * uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function. * suffer from other malignant diseases, i.e. gastric cancer, liver cancer. * pregnant, lactation stage. * metal disorders. * lacking qualified compliance.
References
Publications (9)
- BACKGROUNDSiegel R, Desantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):104-17. doi: 10.3322/caac.21220. Epub 2014 Mar 17. PMID 24639052
- BACKGROUNDBrenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. PMID 24225001
- BACKGROUNDHeald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2. PMID 2425199
- BACKGROUNDMacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w. PMID 8094488
- BACKGROUNDMcLemore EC, Harnsberger CR, Broderick RC, Leland H, Sylla P, Coker AM, Fuchs HF, Jacobsen GR, Sandler B, Attaluri V, Tsay AT, Wexner SD, Talamini MA, Horgan S. Transanal total mesorectal excision (taTME) for rectal cancer: a training pathway. Surg Endosc. 2016 Sep;30(9):4130-5. doi: 10.1007/s00464-015-4680-1. Epub 2015 Dec 10. PMID 26659246
- BACKGROUNDTelem DA, Han KS, Kim MC, Ajari I, Sohn DK, Woods K, Kapur V, Sbeih MA, Perretta S, Rattner DW, Sylla P. Transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) with total mesorectal excision in a large human cadaver series. Surg Endosc. 2013 Jan;27(1):74-80. doi: 10.1007/s00464-012-2409-y. Epub 2012 Jun 30. PMID 22752277
- BACKGROUNDAtallah S, Albert M, Larach S. Transanal minimally invasive surgery: a giant leap forward. Surg Endosc. 2010 Sep;24(9):2200-5. doi: 10.1007/s00464-010-0927-z. Epub 2010 Feb 21. PMID 20174935
- BACKGROUNDKneist W, Hanke L, Kauff DW, Lang H. Surgeons' assessment of internal anal sphincter nerve supply during TaTME - inbetween expectations and reality. Minim Invasive Ther Allied Technol. 2016 Oct;25(5):241-6. doi: 10.1080/13645706.2016.1197269. Epub 2016 Jun 22.