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Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04561830
Collaborator
(none)
60
Enrollment
2
Arms
61
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. operative time [during operative time]

      time of surgery in minutes

    2. operative complication [durning operative time]

      bleed-injury of organs -failed procedure

    3. feasibility of procedure [operative time]

      easy or difficult

    Secondary Outcome Measures

    1. post operative morbidity [5 years]

      early and late complications

    2. mortality [5 years]

      number of deaths

    3. recurrence [5 years]

      recurrent cases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    osama khalil, assistant professor, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT04561830
    Other Study ID Numbers:
    • IR 180033-7
    First Posted:
    Sep 24, 2020
    Last Update Posted:
    Sep 24, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Sep 24, 2020