Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

NCT ID: NCT04561830

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2020-05-31

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1

underwent laparoscopic-assisted excision of mesorectum

Group Type: ACTIVE_COMPARATOR

laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

Intervention Type: PROCEDURE

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.

group 2

open excision of mesorectum

Group Type: ACTIVE_COMPARATOR

laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

Intervention Type: PROCEDURE

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.

Interventions

laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision

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.

Intervention Type: PROCEDURE

Other Intervention Names

open excision of mesorectum with pelvic Lymph nodes excision

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

osama khalil

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IR 180033-7

Identifier Type: -

Identifier Source: org_study_id