Abdominal or Transanal TME for Rectal Cancer Therapy

Study Overview
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Brief Summary
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This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.

Detailed Description
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Rectal cancer accounts for 3.8% of all new cancer diagnosis and for 3.4% of all cancer-related deaths in the world in 2020. Regarding treatment of rectal cancer, it is essential to perform surgery along the anatomical and embryological planes. This technique called total mesorectal excision (TME) reduces the local recurrence rate and improves the survival. Since the early 2000, TME has changed from open to laparoscopic approach due to better results in short-term outcome. Nevertheless, oncological benefits are modest. In 2009 the first ever transanal TME (taTME) war performed. This novel technique combines abdominal with transanal dissection. Because the distal part of the rectum is approached from below, a better visualization of the mesorectal plane resulting in higher rate of free CRM and of complete TME specimen grade (Quirke Score) can be accomplished. However, taTME remains a hot topic in the current scientific literature. In Norway and the Netherlands a higher rate of anastomotic leakage as well as a higher rate of local recurrence (9.5%) with multifocal growth pattern were described.

Official Title
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Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study

Conditions
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Survival, Postoperative Morbidity, Mortality, Recurrence

Intervention / Treatment
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* Procedure: taTME
* Procedure: abdTME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients receiving elective total mesorectal excision Exclusion Criteria: diagnosis other than rectal cancer partial mesorectal excision discontinuity resection (no anastomosis) incomplete Staging metastatic cancer lack of follow-up decline of a retrospective data Analysis age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transanal TME (taTME)<br>patients with rectal cancer receiving transanal TME | Procedure: taTME<br>* Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.<br>* Other names: transanal total mesorectal excision;|
| Active Comparator: abdominal TME (abTME)<br>patients with rectal cancer receiving open, laparoscopic or robotic TME | Procedure: abdTME<br>* Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.<br>* Other names: abdominal total mesorectal excision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | time from surgery to end of follow-up or death | 60 months | 
| cancer-specific survival | time from surgery to end of follow-up or death due to rectal cancer | 60 months | 
| disease-specific survival | time from surgery to end of follow-up or death due to or recurrence of rectal cancer | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive resection margin | tumor extending to the resection margin in pathological examination (R0, R1) | 30 days | 
| Quirke Score | Quality of mesorectal excision in pathological examination (Good, modest, bad) | 30 days | 
| circular resection margin (CRM) | size of circular resection margin (mm) in pathological examination | 30 days | 
| number of lymph nodes | number of lymph nodes in pathological examination | 30 days | 
| postoperative morbidity | Number of patients with postoperative complications (bleeding, anastomotic leakage, ileus, sacral infect, fistula, other surgical complications). The complications will be classified according the Clavien-Dindo-Classification | 30 days | 
| postoperative 90-day mortality | Number of patients who die in the first 90 days after surgery | 90 days | 
| relapse-free survival | local recurrence | 60 months | 
| recurrence-free survival | local or systemic recurrence | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TME, Rectal Cancer, transanal, local recurrence