Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial

NCT05411783 | Unknown DMC

• 1 other identifier: LOTHVEIN
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anastomotic Leak; Anastomotic Leak Large Intestine; Anastomotic Leak Rectum; Colon Cancer; Colon Neoplasm; Rectum Cancer; Rectum Neoplasm; Colorectal Cancer

Keywords

colorectal surgery; IMV tie; anastomotic leak

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak

  Anastomotic leak clinically or radiologically evident

  30 day

Secondary Outcomes (1)

• Post-operative complications

  30 day

Study Arms (2)

High tie of IMV

NO INTERVENTION

The IMV will be tie under the pancreas as the usual procedure in left hemicolectomy and ARR

Low tie of IMV

EXPERIMENTAL

The IMV will be tie under the left colic vein

Procedure: Low tie of IMV

Interventions

Low tie of IMV PROCEDURE

The IMV will be tie under the left colic vein

Low tie of IMV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenoma or adenocarcinoma of left colon or upper rectum without neoajuvant RCT
• No distant metastasis

You may not qualify if:

• Previous colonic surgery
• emergency surgery
• Previous pelvic radiation

Sponsors & Collaborators

• San Carlo di Nancy Hospital: lead

Study Sites (1)

San Carlo di Nancy Hospital

Roma, RM, 00175, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 33042104 BACKGROUND

• 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.

  PMID: 35092916 BACKGROUND

• 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.

  PMID: 30903276 BACKGROUND

• Rojas-Machado SA, Romero-Simo M, Arroyo A, Rojas-Machado A, Lopez 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.

  PMID: 26507962 BACKGROUND

• 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. doi: 10.1016/s1072-7515(00)00709-2.

  PMID: 11085730 BACKGROUND

• 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.

  PMID: 30963345 BACKGROUND

• 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.

  PMID: 22513429 BACKGROUND

• 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. doi: 10.2214/ajr.168.5.9129413.

  PMID: 9129413 BACKGROUND

• Garcia-Granero A, Pellino G, Frasson M, Primo Romaguera V, Fletcher-Sanfeliu D, Blasco Serra A, Valverde-Navarro AA, Martinez-Soriano F, Garcia-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. No abstract available.

  PMID: 31321633 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak; Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

IT (1)