Trials / Completed
CompletedNCT04561830
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Zagazig University · Other Government
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2020-01-01
- Completion
- 2020-05-01
- First posted
- 2020-09-24
- Last updated
- 2020-09-24
Source: ClinicalTrials.gov record NCT04561830. Inclusion in this directory is not an endorsement.