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Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma

Primary Purpose

Rectal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
total mesorectal excision in rectal carcinoma
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Carcinoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria. Both sexes will be included. Age: ranging from 20 to 70 years. Exclusion Criteria: Patients with stage IV. Recurrent rectal cancers. Combined malignancy. Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage). Patients with contraindication for laparoscopic surgery. Unfit patients (ASA score > II).

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A laparoscopic group

Group B

Arm Description

group A laparoscopic surgery

Group B open surgery

Outcomes

Primary Outcome Measures

Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.
R(resection margin of cancer of rectum) CRM circumferencial margin Or. DRM distal resection margin of cancer

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
January 12, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05685680
Brief Title
Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma
Official Title
Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Although the best efforts of experienced surgeons, The local recurrence rate is 3 to 33% in conventional surgery, while total mesorectal excision (TME) results indicate a recurrence rate of less than 10% The evolution of the concept of TME which was first revealed by Heald.in 1982 made a major shift in the treatment strategies (Rodriguez-Luna et al,2015). The concept of TME was the most important event in surgery for rectal cancer in the last two decades, because even without a curative approach, the local recurrence decreased to 6 to 12%, and 5-year survival improved by 53-87% TME described clear definitions of distal resection margin (DRM), circumferential resection margin (CRM), and least number of harvested lymph nodes, so oncological outcomes improved, locoregional recurrence and survival rates also influenced . Laparoscopic total mesorectal excision (LTME) may be associated with less blood loss, earlier recovery, and lower morbidity. Identification of the small nerves and vessels became easiear because of laparoscopic magnified view of pelvis and thus prevents these injuries (Sajid et al, 2019). Also, minimal surgical trauma will reduce the immunologic response and preserves postoperative immunologic defenses. This may lead to low rate of infections as well as low local recurrences and distant metastases in addition to, tissue handling with less manipulation, 'may reduces the spread of cancer cells TME in obese males with low and anterior rectal tumors is technically challenging especially post neoadjuvant chemoradiotherapy due to distortion of the anatomical planes (Ng et al, 2014). In these patients, it is difficult to obtain a proper view of the dissection plane, in open technique which threatens the integrity of TME and carries the risk of positive margins, which is related to higher rates of local recurrence LTME is a widely used approach for rectal cancers; although conversion rate varies from 1.2 to 17%, and it is higher if BMI is equal to or more than 30

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A laparoscopic group
Arm Type
Active Comparator
Arm Description
group A laparoscopic surgery
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B open surgery
Intervention Type
Procedure
Intervention Name(s)
total mesorectal excision in rectal carcinoma
Intervention Description
total mesorectal excision laparoscopic versus open technique in management of rectal carcinoma
Primary Outcome Measure Information:
Title
Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.
Description
R(resection margin of cancer of rectum) CRM circumferencial margin Or. DRM distal resection margin of cancer
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria. Both sexes will be included. Age: ranging from 20 to 70 years. Exclusion Criteria: Patients with stage IV. Recurrent rectal cancers. Combined malignancy. Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage). Patients with contraindication for laparoscopic surgery. Unfit patients (ASA score > II).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
osama s saleh, assistant lecture
Phone
01119966457
Email
usama.mohamed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
omar A abd el-raheem, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
15164243
Citation
Cecil TD, Sexton R, Moran BJ, Heald RJ. Total mesorectal excision results in low local recurrence rates in lymph node-positive rectal cancer. Dis Colon Rectum. 2004 Jul;47(7):1145-9; discussion 1149-50. doi: 10.1007/s10350-004-0086-6. Epub 2004 Jun 3.
Results Reference
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PubMed Identifier
17195085
Citation
Braga M, Frasson M, Vignali A, Zuliani W, Capretti G, Di Carlo V. Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis. Dis Colon Rectum. 2007 Apr;50(4):464-71. doi: 10.1007/s10350-006-0798-5.
Results Reference
background
PubMed Identifier
9667714
Citation
Hill GL, Rafique M. Extrafascial excision of the rectum for rectal cancer. Br J Surg. 1998 Jun;85(6):809-12. doi: 10.1046/j.1365-2168.1998.00735.x.
Results Reference
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Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma

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