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

NCT05685680 | Unknown

• 1 other identifier: Soh-Med-22-12-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  1year

Study Arms (2)

Group A laparoscopic group

ACTIVE COMPARATOR

group A laparoscopic surgery

Procedure: total mesorectal excision in rectal carcinoma

Group B

ACTIVE COMPARATOR

Group B open surgery

Procedure: total mesorectal excision in rectal carcinoma

Interventions

total mesorectal excision in rectal carcinoma PROCEDURE

total mesorectal excision laparoscopic versus open technique in management of rectal carcinoma

Group A laparoscopic group; Group B

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 15164243 BACKGROUND

• 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.

  PMID: 17195085 BACKGROUND

• 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.

  PMID: 9667714 BACKGROUND

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

Central Study Contacts

osama s saleh, assistant lecture

CONTACT

01119966457; usama.mohamed@med.sohag.edu.eg

omar A abd el-raheem, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture ofgeneral surgery

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 17, 2023
• Study Start: December 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 17, 2023

Record last verified: 2022-12

Locations

EG (1)