Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

• Registration Number: NCT04561830
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2020-01
• Study Completion: 2020-05
• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-19
• Last Update Submitted: 2020-09-19
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision	open excision of mesorectum
group 1	laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision	underwent laparoscopic-assisted excision of mesorectum

Primary Outcome Measures

Name	Time	Method
feasibility of procedure	operative time	easy or difficult
operative complication	durning operative time	bleed-injury of organs -failed procedure
operative time	during operative time	time of surgery in minutes

Secondary Outcome Measures

Name	Time	Method
mortality	5 years	number of deaths
recurrence	5 years	recurrent cases
post operative morbidity	5 years	early and late complications