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The purpose of this study is to explore the different impacts of high and low ligation in laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still a controversial subject between the advocates of high and low ligation. The low ligation is defined as the IMA is ligated below the origin of the left colic artery while the high ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of laparoscopy has encouraged more frequent execution of the high ligation, which appears easier to achieve than the low ligation and also with the advantage of lower anastomosis traction but with the disadvantage of worse vascularization of the stumps as well.
It has long been debated that whether to tie off the inferior mesenteric artery (IMA) at its origin or just below the origin of the left colic artery (LCA) of the anterior resection of the rectum. Thus far, no clear consensus has been achieved, and the level of arterial ligation still varies among institutions and patients. In the previous studies, high or low ligation takes advantage on both sides. However, there are still some researches that have demonstrated no significant difference had been found in the incidence of anastomotic leakage and other complications between the high and low ligation groups. Therefore, to provide a clear and definite answer to surgeons of how they should deal with the IMA in laparoscopy rectal surgery. We plan to explore the impacts of high and low tie in laparoscopic anterior rectal resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival by prospective and multi-center clinical trial.
Surgery will be described as follows:
For low ligation group:
For high ligation groups:
Laparoscopic surgery is performed. The IMA is ligated and divided at 2 cm. from its origin. Dissect the adipose tissue and lymph nodes around IMA. The inferior mesenteric vein (IMV) is divided and ligated below the duodenal margin. The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen. For both groups Total Mesolectal Excision (TME) is performed according to the principles of Heald.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low ligation | Experimental | Left colic artery (LCA) is identified, tie the sigmoid artery and superior rectal artery,Apical lymph node dissection with the left colic artery preservation is performed. |
|
| High ligation | Active Comparator | The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low ligation | Procedure | Left colic artery (LCA) is identified, Tie the sigmoid artery and superior rectal artery, Apical lymph node dissection with the left colic artery preservation is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leakage | Anastomosis leakage rate after surgery, acute or chronic | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| proximal bowel necrosis | Proximal bowel necrosis rate after surgery, acute or chronic | 3 months |
| proximal bowel stenosis | Proximal bowel stenosis rate after surgery, acute or chronic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Zou, MD | Contact | 0086-15874865802 | zouting218@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei dong Liu, MD | Xiangya Hospital of Central South University | Principal Investigator |
| Xi Xie, MD | Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22820922 | Background | Milnerowicz S, Milnerowicz A, Tabola R. A middle mesenteric artery. Surg Radiol Anat. 2012 Dec;34(10):973-5. doi: 10.1007/s00276-012-0987-y. Epub 2012 Jul 22. | |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
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we would like to share our data.
Around 2025
Someone who has the same or similar research could contact us at davidcsu@foxmail.com
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Procedure: Low ligation with apical lymph node dissection
Procedure: High ligation with apical lymph node dissection
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|
| High ligation | Procedure | The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed. |
|
|
| 3 months |
| Characteristics of the division branches of the inferior mesenteric artery in Chinese people | e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm). | 1-2 days |
| Apical Lymph Nodes Positive Rate | Apical Lymph Nodes Positive Rate | 14 days |
| Conversion rate to laparotomy | Conversion rate to laparotomy | 5-years |
| Complications of defunctioning stoma | Complications of defunctioning stoma | 3 months |
| Early postoperative complications: Anastomotic bleeding, etc. | Early postoperative complications: Anastomotic bleeding, etc. | 30 days |
| Anastomosis stenosis rate after surgery | Anastomosis stenosis rate after surgery | 30 days |
| Mortality rate in 3 months after surgery | Mortality rate in 3 months after surgery | 3 months |
| Life quality | Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)). | 5-years |
| Micturition function scoring | Micturition function is measured by questionnaire(IPSS). | 3 months |
| Sexual function scoring | Sexual function is measured by questionnaire(The IIEF-5 questionnaire). | 3 months |
| 5-years overall survival rate | 5-years overall survival rate | 5-years |
| 5-years disease free survival rate | 5-years disease free survival rate | 5-years |
| 27999945 | Background | Kim DI, Han SH. A rare branching pattern of hindgut: absence of inferior mesenteric artery. Surg Radiol Anat. 2017 Jul;39(7):803-806. doi: 10.1007/s00276-016-1770-2. Epub 2016 Dec 20. |
| 24745995 | Background | Vermeer TA, Orsini RG, Daams F, Nieuwenhuijzen GA, Rutten HJ. Anastomotic leakage and presacral abscess formation after locally advanced rectal cancer surgery: Incidence, risk factors and treatment. Eur J Surg Oncol. 2014 Nov;40(11):1502-9. doi: 10.1016/j.ejso.2014.03.019. Epub 2014 Apr 4. |
| 28386743 | Background | Abe T, Ujiie A, Taguchi Y, Satoh S, Shibuya T, Jun Y, Isogai S, Satoh YI. Anomalous inferior mesenteric artery supplying the ascending, transverse, descending, and sigmoid colons. Anat Sci Int. 2018 Jan;93(1):144-148. doi: 10.1007/s12565-017-0401-2. Epub 2017 Apr 6. |
| 20004450 | Background | Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11. |
| 27401339 | Background | Smedh K, Sverrisson I, Chabok A, Nikberg M; HAPIrect Collaborative Study Group. Hartmann's procedure vs abdominoperineal resection with intersphincteric dissection in patients with rectal cancer: a randomized multicentre trial (HAPIrect). BMC Surg. 2016 Jul 11;16(1):43. doi: 10.1186/s12893-016-0161-2. |
| 10333426 | Background | Hida J, Yasutomi M, Maruyama T, Uchida T, Nakajima A, Wakano T, Tokoro T, Kubo R. High ligation of the inferior mesenteric artery with hypogastric nerve preservation in rectal cancer surgery. Surg Today. 1999;29(5):482-3. doi: 10.1007/BF02483047. |
| 25623323 | Background | Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5. |
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| 7745320 | Background | Hall NR, Finan PJ, Stephenson BM, Lowndes RH, Young HL. High tie of the inferior mesenteric artery in distal colorectal resections--a safe vascular procedure. Int J Colorectal Dis. 1995;10(1):29-32. doi: 10.1007/BF00337583. |
| 22071020 | Background | Cirocchi R, Farinella E, Trastulli S, Desiderio J, Di Rocco G, Covarelli P, Santoro A, Giustozzi G, Redler A, Avenia N, Rulli A, Noya G, Boselli C. High tie versus low tie of the inferior mesenteric artery: a protocol for a systematic review. World J Surg Oncol. 2011 Nov 9;9:147. doi: 10.1186/1477-7819-9-147. |
| 24633578 | Background | Bertrand MM, Delmond L, Mazars R, Ripoche J, Macri F, Prudhomme M. Is low tie ligation truly reproducible in colorectal cancer surgery? Anatomical study of the inferior mesenteric artery division branches. Surg Radiol Anat. 2014 Dec;36(10):1057-62. doi: 10.1007/s00276-014-1281-y. Epub 2014 Mar 15. |
| 13967713 | Background | BERNSTEIN WC, BERNSTEIN EF. Ischemic ulcerative colitis following inferior mesenteric arterial ligation. Dis Colon Rectum. 1963 Jan-Feb;6:54-61. doi: 10.1007/BF02617232. No abstract available. |
| 27334448 | Background | Francone E, Bonfante P, Bruno MS, Intersimone D, Falco E, Berti S. Laparoscopic Inferior Mesenteric Artery Peeling: An Alternative to High or Low Vascular Ligation for Sigmoid Colon Cancer Resection. World J Surg. 2016 Nov;40(11):2790-2795. doi: 10.1007/s00268-016-3611-1. |
| 28766076 | Background | Zhang W, Lou Z, Liu Q, Meng R, Gong H, Hao L, Liu P, Sun G, Ma J, Zhang W. Multicenter analysis of risk factors for anastomotic leakage after middle and low rectal cancer resection without diverting stoma: a retrospective study of 319 consecutive patients. Int J Colorectal Dis. 2017 Oct;32(10):1431-1437. doi: 10.1007/s00384-017-2875-8. Epub 2017 Aug 2. |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |