Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Zagazig University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

laparoscopic-assited excision of mesorectum with pelvic lymph nodes excisionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

operative time

time of surgery in minutes

Time frame: during operative time

operative complication

bleed-injury of organs -failed procedure

Time frame: durning operative time

feasibility of procedure

easy or difficult

Time frame: operative time

Secondary Outcomes

post operative morbidity

early and late complications

Time frame: 5 years

mortality

number of deaths

Time frame: 5 years

recurrence

recurrent cases

Time frame: 5 years

Data from ClinicalTrials.gov

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