Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Study Overview
=================
Brief Summary
-----------------
To compare the open approach and the laparoscopic-assisted approach of dissection of lateral lymph nodes in low advanced rectal cancer patients with clinically suspected nodal metastases in terms of safety, technical feasibility, and patient's oncological outcomes.

Detailed Description
-----------------
the investigators collected data of sixty low advanced cancer rectum patients who underwent either laparoscopic (30 cases) or open total mesorectal excision (30 cases) in addition to lateral pelvic dissection. The duration of operation in the laparoscopically assisted procedure was longer than the open procedure (p=0.003). The postoperative hospital stay time was longer in the open group than in the laparoscopic group (P=0.043). No significant differences between both groups regarding the number of excised lymph nodes, disease recurrence, RFS, or OS rate.

Official Title
-----------------
Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach

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

Intervention / Treatment
-----------------
* Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 20-70 years with Sure diagnosis of locally advanced (T3 and T4) adenocarcinoma located in the middle or lower part of the rectum Clinical or radiological evidence of lateral pelvic lymph nodes metastases Exclusion Criteria: Patients refused to be included in the study, Patients with concurrent primary cancer in other locations Patients with recurrent cancer after treatment Patients with distant metastasis Previously managed for pelvic cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

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: group 1<br>underwent laparoscopic-assisted excision of mesorectum | Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision<br>* We performed laparoscopic dissection of the lateral pelvic lymph node for thirty patients while we performed open lateral pelvic lymph node dissection for the remaining thirty patients. Performed surgical approaches were abdominoperineal resection, internal sphincter resection, and low anterior resection. All performed surgical procedures included lateral pelvic lymphadenectomy in addition to performing total mesorectal excision. Choosing whether to perform unilateral or bilateral lymphadenectomy depends on lymph nodes invasion by cancer was on one side or both sides.<br>* Other names: open excision of mesorectum with pelvic Lymph nodes excision;|
| Active Comparator: group 2<br>open excision of mesorectum | Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision<br>* We performed laparoscopic dissection of the lateral pelvic lymph node for thirty patients while we performed open lateral pelvic lymph node dissection for the remaining thirty patients. Performed surgical approaches were abdominoperineal resection, internal sphincter resection, and low anterior resection. All performed surgical procedures included lateral pelvic lymphadenectomy in addition to performing total mesorectal excision. Choosing whether to perform unilateral or bilateral lymphadenectomy depends on lymph nodes invasion by cancer was on one side or both sides.<br>* Other names: open excision of mesorectum with pelvic Lymph nodes excision;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | time of surgery in minutes | during operative time | 
| operative complication | bleed-injury of organs -failed procedure | durning operative time | 
| feasibility of procedure | easy or difficult | operative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative morbidity | early and late complications | 5 years | 
| mortality | number of deaths | 5 years | 
| recurrence | recurrent cases | 5 years |