Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the surgical, oncological and functional outcome of either the laparoscopic or trans-anal TME in management of mid and low rectal cancer.

Detailed Description
-----------------
Colorectal cancer (CRC) is considered the third most common type of cancer all over the world and the fourth common cause of cancer-specific mortality.Surgical management for rectal cancer is challenging due to the narrow pelvis and extreme proximity to contiguous organs hence, recurrence rates are commonly reported. The advent of total mesorectal excision (TME) together with minimally invasive techniques such as laparoscopic colorectal surgery have not only improved surgical results but have also improved surgical technique, operative ability and surgical visibility. Lap TME has been shown to give similar results to the classical open approach with regard to peri-operative morbidity, surgical margins, quality of the surgical specimen, and number of resected lymph nodes, local recurrence and overall survival. However, laparoscopic resection of mid and low rectal cancer is technically difficult due to tapering of the mesorectum in the pelvis and the forward angle of the distal rectum rendering this part of the rectum less accessible from the abdominal cavity. This may lead to incomplete mesorectal excision and involved circumferential resection margins (CRMs), with consequent local recurrences.Previous pelvic radiation can make laparoscopic pelvic dissection more difficult, and tumors located on the anterior rectal wall have an increased risk of inadequate oncological clearance. The use of laparoscopic staplers in a narrow pelvis is difficult and the multiple firings of staples across the low rectum is of concern. Trans-anal Total Mesorectal Excision (TaTME) was recently developed to overcome technical difficulties associated with Lap TME and open TME. It may address some of the difficult aspects of laparoscopic or open TME, such as exposure, rectal dissection, and distal cross-stapling of the rectum and sphincter preservation. It does not only facilitate dissection of the difficult distal part of the TME dissection in the narrow pelvis but it also allows clear definition of safe, tumor-free, radial and longitudinal margins. Moreover, the specimen could be extracted through the anus excluding the need for minilaparotmy.

Official Title
-----------------
(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Trans-anal total mesorectal excision(TaTME)
* Procedure: Lap. TME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthetically fit patient. Non metastatic pathologically proven rectal cancer (Mid-Low). Patients who received neoadjuvant chemo-radiotherapy will be included Exclusion Criteria: Patients with American Society of Anesthesiologist (ASA) score 4 and 5. Patients with cardiac or chest problems that cannot withstand CO2 insufflation. Unresectable tumors (T4) (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation). Obstructed or perforated cancer. Patients with unresectable metastatic rectal cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-anal TME (TaTME)<br>Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation) | Procedure: Trans-anal total mesorectal excision(TaTME)<br>* Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)<br>* Other names: Bottom to up approach;|
| Active Comparator: Lap. TME<br>Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection | Procedure: Lap. TME<br>* Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumferential radial margin (CRM) | Percentage of participants with involved circumferential margin(pathological assessment) | 2 years | 
| Distal safety margin | Distance of free distal margin in mm (pathological assessment) | 2 years | 
| Number of lymph nodes retrieved | Number of infiltrated/ Number of harvested lymph nodes(pathological assessment) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate | Number of intra-operative and post-operative encountered complications | 2 years | 
| Rate of conversion | Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases | 2 years | 
| Disease free survival | Time till development of local or distant recurrence in months | 30 months | 
| Functional outcome | Assessment of functional outcome via questionnaires | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally invasive surgery, trans-anal total mesorectal excision, Laparoscopic total mesoretal excision