Back to resultsOpen or Laparoscopic Mesolectal Excision in Low Rectum Cancer
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
underwent laparoscopic-assisted excision of mesorectum
open excision of mesorectum
Outcomes
Primary Outcome Measures
operative time
time of surgery in minutes
operative complication
bleed-injury of organs -failed procedure
feasibility of procedure
easy or difficult
Secondary Outcome Measures
post operative morbidity
early and late complications
mortality
number of deaths
recurrence
recurrent cases
Full Information
NCT ID
NCT04561830
First Posted
September 15, 2020
Last Updated
September 19, 2020
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT04561830
Brief Title
Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer
Official Title
Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
underwent laparoscopic-assisted excision of mesorectum
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
open excision of mesorectum
Intervention Type
Procedure
Intervention Name(s)
laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision
Other Intervention Name(s)
open excision of mesorectum with pelvic Lymph nodes excision
Intervention Description
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.
Primary Outcome Measure Information:
Title
operative time
Description
time of surgery in minutes
Time Frame
during operative time
Title
operative complication
Description
bleed-injury of organs -failed procedure
Time Frame
durning operative time
Title
feasibility of procedure
Description
easy or difficult
Time Frame
operative time
Secondary Outcome Measure Information:
Title
post operative morbidity
Description
early and late complications
Time Frame
5 years
Title
mortality
Description
number of deaths
Time Frame
5 years
Title
recurrence
Description
recurrent cases
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer
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