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OpenTrials
Completed

NCT Number: NCT04561830

Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: open excision of mesorectum with pelvic Lymph nodes excision

Primary outcomes

  1. operative time

    Time frame: during operative time

    time of surgery in minutes

  2. operative complication

    Time frame: durning operative time

    bleed-injury of organs -failed procedure

  3. feasibility of procedure

    Time frame: operative time

    easy or difficult

Secondary outcomes

  1. post operative morbidity

    Time frame: 5 years

    early and late complications

  2. mortality

    Time frame: 5 years

    number of deaths

  3. recurrence

    Time frame: 5 years

    recurrent cases

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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