Clinical trial · Interventional
Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial
Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial. LOTHVEIN Study
NCT05411783CI-TRIAL-00059002LOTHVEINunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Anastomotic Leak Large Intestine | — | UNRESOLVED | — |
| Anastomotic Leak Rectum | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Neoplasm | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
| Rectum Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low tie of IMV | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- High tie of IMV
- description
- The IMV will be tie under the pancreas as the usual procedure in left hemicolectomy and ARR
- type
- EXPERIMENTAL
- label
- Low tie of IMV
- description
- The IMV will be tie under the left colic vein
- interventionNames
- Procedure: Low tie of IMV
Primary outcomes (1)
- measure
- Anastomotic leak
- timeFrame
- 30 day
- description
- Anastomotic leak clinically or radiologically evident
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDJohdi 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
- BACKGROUNDChiarello 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
- BACKGROUNDDe 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
- BACKGROUNDRojas-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
- BACKGROUNDBoyle 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
- BACKGROUNDGirard 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
- 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.