Colorectal Cancer Clinical Trial
— LOTHVEINOfficial title:
Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial. LOTHVEIN Study
NCT number | NCT05411783 |
Other study ID # | LOTHVEIN |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | June 1, 2023 |
Verified date | June 2022 |
Source | San Carlo di Nancy Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aim to determine if a different surgical technique could result in a lower anastomotic leak rate. The two techniques are equally used around the world and well described by the international literature but this is the first study that compare the two techniques.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Adenoma or adenocarcinoma of left colon or upper rectum without neoajuvant RCT - No distant metastasis Exclusion Criteria: - Previous colonic surgery - emergency surgery - Previous pelvic radiation |
Country | Name | City | State |
---|---|---|---|
Italy | San Carlo di Nancy Hospital | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
San Carlo di Nancy Hospital |
Italy,
Bonnet S, Berger A, Hentati N, Abid B, Chevallier JM, Wind P, Delmas V, Douard R. High tie versus low tie vascular ligation of the inferior mesenteric artery in colorectal cancer surgery: impact on the gain in colon length and implications on the feasibility of anastomoses. Dis Colon Rectum. 2012 May;55(5):515-21. doi: 10.1097/DCR.0b013e318246f1a2. — View Citation
Boyle NH, Manifold D, Jordan MH, Mason RC. Intraoperative assessment of colonic perfusion using scanning laser Doppler flowmetry during colonic resection. J Am Coll Surg. 2000 Nov;191(5):504-10. — View Citation
Chiarello MM, Fransvea P, Cariati M, Adams NJ, Bianchi V, Brisinda G. Anastomotic leakage in colorectal cancer surgery. Surg Oncol. 2022 Mar;40:101708. doi: 10.1016/j.suronc.2022.101708. Epub 2022 Jan 24. Review. — View Citation
De Nardi P, Elmore U, Maggi G, Maggiore R, Boni L, Cassinotti E, Fumagalli U, Gardani M, De Pascale S, Parise P, Vignali A, Rosati R. Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc. 2020 Jan;34(1):53-60. doi: 10.1007/s00464-019-06730-0. Epub 2019 Mar 21. — View Citation
García-Granero A, Pellino G, Frasson M, Primo Romaguera V, Fletcher-Sanfeliu D, Blasco Serra A, Valverde-Navarro AA, Martinez-Soriano F, García-Granero E. Possible effects of height of ligation of the inferior mesenteric vein on venous return of the colorectal anastomosis: the venous trunk theory. Tech Coloproctol. 2019 Aug;23(8):799-800. doi: 10.1007/s10151-019-02038-2. Epub 2019 Jul 18. — View Citation
Girard E, Trilling B, Rabattu PY, Sage PY, Taton N, Robert Y, Chaffanjon P, Faucheron JL. Level of inferior mesenteric artery ligation in low rectal cancer surgery: high tie preferred over low tie. Tech Coloproctol. 2019 Mar;23(3):267-271. doi: 10.1007/s10151-019-01931-0. Epub 2019 Apr 8. — View Citation
Graf O, Boland GW, Kaufman JA, Warshaw AL, Fernandez del Castillo C, Mueller PR. Anatomic variants of mesenteric veins: depiction with helical CT venography. AJR Am J Roentgenol. 1997 May;168(5):1209-13. — View Citation
Johdi NA, Sukor NF. Colorectal Cancer Immunotherapy: Options and Strategies. Front Immunol. 2020 Sep 18;11:1624. doi: 10.3389/fimmu.2020.01624. eCollection 2020. Review. — View Citation
Rojas-Machado SA, Romero-Simó M, Arroyo A, Rojas-Machado A, López J, Calpena R. Prediction of anastomotic leak in colorectal cancer surgery based on a new prognostic index PROCOLE (prognostic colorectal leakage) developed from the meta-analysis of observational studies of risk factors. Int J Colorectal Dis. 2016 Feb;31(2):197-210. doi: 10.1007/s00384-015-2422-4. Epub 2015 Oct 27. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anastomotic leak | Anastomotic leak clinically or radiologically evident | 30 day | |
Secondary | Post-operative complications | Any post-operative complication | 30 day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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