Clinical Trials Directory

Trials / Completed

CompletedNCT04561830

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElaparoscopic-assited excision of mesorectum with pelvic lymph nodes excisionWe 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.

Timeline

Start date
2015-04-01
Primary completion
2020-01-01
Completion
2020-05-01
First posted
2020-09-24
Last updated
2020-09-24

Source: ClinicalTrials.gov record NCT04561830. Inclusion in this directory is not an endorsement.