Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

NCT04561830 | Completed DMC

• 1 other identifier: IR 180033-7
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• post operative morbidity

  5 years

• mortality

  5 years

• recurrence

  5 years

Study Arms (2)

group 1

ACTIVE COMPARATOR

underwent laparoscopic-assisted excision of mesorectum

Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

group 2

ACTIVE COMPARATOR

open excision of mesorectum

Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

Interventions

laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision PROCEDURE

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.

Also known as: open excision of mesorectum with pelvic Lymph nodes excision

group 1; group 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 24, 2020
• Study Start: April 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share