Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Zagazig University

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

Study type: Interventional

Funder types: Other

Identifiers

NCT04561830

IR 180033-7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

group 1

Active Comparator group

Description:

underwent laparoscopic-assisted excision of mesorectum

Treatment:

Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

group 2

Active Comparator group

Description:

open excision of mesorectum

Treatment:

Procedure: laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision