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Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Cancer

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ClinicalTrials.gov Identifier: NCT03557528
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
DANIELE CROCETTI, University of Roma La Sapienza

Brief Summary:
During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.

Condition or disease Intervention/treatment
Rectosigmoid Adenocarcinoma Procedure: Laparoscopic colorectal resection

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of the Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Tumors
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : April 30, 2017

Group/Cohort Intervention/treatment
Group 1
High Ligation of Inferior mesenteric artery
Procedure: Laparoscopic colorectal resection
Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes

Group 2
Low ligation of inferior mesenteric artery with skeletonization at its origin
Procedure: Laparoscopic colorectal resection
Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes




Primary Outcome Measures :
  1. effectivenes of lymphnode dissection [ Time Frame: 3 years ]
    number of dissected lymphnodes


Secondary Outcome Measures :
  1. complication [ Time Frame: 3 years ]
    incidence of anasthomotic leaks



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients affectced by clinical stage I-III cancer of sigmoid and rectum.
Criteria

Inclusion Criteria:

  • stage I-III carcinoma

Exclusion Criteria:

  • stage IV
  • Urgent resection
  • conversion to open surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557528


Locations
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Italy
Policlinico Umberto I
Roma, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza

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Responsible Party: DANIELE CROCETTI, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03557528     History of Changes
Other Study ID Numbers: 14ur2018
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms