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Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer

Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561830
Enrollment
60
Registered
2020-09-24
Start date
2015-04-30
Completion date
2020-05-31
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

PROCEDURElaparoscopic-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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
operative timeduring operative timetime of surgery in minutes
operative complicationdurning operative timebleed-injury of organs -failed procedure
feasibility of procedureoperative timeeasy or difficult

Secondary

MeasureTime frameDescription
mortality5 yearsnumber of deaths
recurrence5 yearsrecurrent cases
post operative morbidity5 yearsearly and late complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026