Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; underwent laparoscopic-assisted excision of mesorectum	Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision; 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.; Other Names: open excision of mesorectum with pelvic Lymph nodes excision
Active Comparator: group 2; open excision of mesorectum	Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision; 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.; 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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: IR 180033-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No