Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
2. Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
3. Curative rectal cancer surgery;
4. No evidence of distance metastasis lesions;
5. T1-3, N0-2, with or without neoadjuvant therapeutic history;
6. Applied to laparoscopic surgery;
7. Absent of previous malignancy-treated history
8. No gender restriction, age between 18 and 75, Body Mass Index less than 32;
9. Approved by multiple disciplinary teamwork therapeutic group
10. Consent by the patient and the family.

Exclusion Criteria:

1. Mile's surgery is additionally required;
2. Tumor invasion is validated on adjacent organs, such as prostate;
3. Recurrent rectal cancer, require secondary surgical interventions;
4. Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
5. Emergent surgery accompanied by bowel obstruction or intestinal perforation;
6. Previous history of colorectal surgery, unnatural anatomical structure;
7. Contraindication to general anesthesia (class IV or V in American Society of Anesthesiologists (ASA), or Eastern Cooperative Oncology Group (ECOG) score \>=2)
8. Pregnant or breast-feeding patients;
9. Mental disorder validated by psychiatrists.
10. Uncontrolled infectious diseases;
11. Participants within other related clinical trials that may influence the conclusion of this trial;

• BACKGROUNDMotson RW, Whiteford MH, Hompes R, Albert M, Miles WF; Expert Group. Current status of trans-anal total mesorectal excision (TaTME) following the Second International Consensus Conference. Colorectal Dis. 2016 Jan;18(1):13-8. doi: 10.1111/codi.13131. PMID 26400670
• BACKGROUNDBulut O, Levic K, Hesselfeldt P, Bulow S. The outcome of rectal cancer after early salvage TME following TEM compared with primary TME: a case-matched study. Tech Coloproctol. 2014 Jan;18(1):83-4. doi: 10.1007/s10151-013-1083-y. Epub 2013 Nov 6. No abstract available. PMID 24197900
• BACKGROUNDMartin-Perez B, Andrade-Ribeiro GD, Hunter L, Atallah S. A systematic review of transanal minimally invasive surgery (TAMIS) from 2010 to 2013. Tech Coloproctol. 2014 Sep;18(9):775-88. doi: 10.1007/s10151-014-1148-6. Epub 2014 May 7. PMID 24848524
• RESULTFernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865. PMID 25185463