Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561830
• Other study ID #: IR 180033-7
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2020

Study information

• Verified date: September 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	time of surgery in minutes	during operative time
Primary	operative complication	bleed-injury of organs -failed procedure	durning operative time
Primary	feasibility of procedure	easy or difficult	operative time
Secondary	post operative morbidity	early and late complications	5 years
Secondary	mortality	number of deaths	5 years
Secondary	recurrence	recurrent cases	5 years