Rectal CancerPLANDNCT03498885
Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer
A study testing Low ligation and High ligation in people with Rectal Cancer, run by WEIDONG LIU，MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Low ligation and High ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years to 75 Years (Adult, Senior).
- Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
- Tumor located at 4-15 cm from the dentate line.
- The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
- Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
- Anus-saving operation is available.
Show all 10Show fewer
- ASA class: I-III.
- Well tolerate to general anesthesia.
- ECOG score: 0-1.
- Patients - can understand and are willing to take part in the clinical trial.
Who cannot join
- Severe cardiovascular disease, uncontrollable infection or other severe complications.
- Severe mental illness.
- Suffer with other carcinoma simultaneously or sequentially in 5 years.
- Familial polyposis coli or Multiple -colorectal tumor.
- History of abdominal surgery and with severe abdominal adhesions.
- Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
Show all 17Show fewer
- Multiple organs resection surgery is needed.
- Abdominoperineal resection need to be performed.
- ASA class: IV to V.
- Pregnant, suckling period or reject to birth control.
- Patient who unable to go through the clinical trial because of familial,social or religious factors.
- Refuse to take part in the trial.
- Patients without an informed consent.
- Non-compliant patient
- The patient or their family members want to withdraw from the clinical trial.
- Loss to follow-up
- Researchers think the participants need to withdraw from the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Liu wei dong, doctor, 0086-13873124855, davidcsu@foxmail.com
About this study
Official title: Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
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.
Read the detailed description
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:
- Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen.
- Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level.
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.
- Conditions
- Rectal Cancer
- Being tested
- Low ligation, High ligation
- Keywords
- Rectal Cancer, inferior mesenteric artery, Laparoscopic
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low ligationProcedure or surgery
Also called LL
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 ligationProcedure or surgery
Also called HL
The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Low ligation |
| High ligation | Active comparator | The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed. Receives: Procedure: High ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Anastomosis leakage rate after surgery, acute or chronic
Measured: 3 months
Secondary outcomes (14)
proximal bowel necrosis
Proximal bowel necrosis rate after surgery, acute or chronic
Measured: 3 months
proximal bowel stenosis
Proximal bowel stenosis rate after surgery, acute or chronic
Measured: 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).
Measured: 1-2 days
Apical Lymph Nodes Positive Rate
Apical Lymph Nodes Positive Rate
Measured: 14 days
Conversion rate to laparotomy
Conversion rate to laparotomy
Measured: 5-years
Complications of defunctioning stoma
Complications of defunctioning stoma
Measured: 3 months
Early postoperative complications: Anastomotic bleeding, etc.
Early postoperative complications: Anastomotic bleeding, etc.
Measured: 30 days
Anastomosis stenosis rate after surgery
Anastomosis stenosis rate after surgery
Measured: 30 days
Mortality rate in 3 months after surgery
Mortality rate in 3 months after surgery
Measured: 3 months
Life quality
Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
Measured: 5-years
Micturition function scoring
Micturition function is measured by questionnaire(IPSS).
Measured: 3 months
Sexual function scoring
Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
Measured: 3 months
5-years overall survival rate
5-years overall survival rate
Measured: 5-years
5-years disease free survival rate
5-years disease free survival rate
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Procedure： Low ligation with apical lymph node dissection Procedure： High ligation with apical lymph node dissection
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WEIDONG LIU，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WEIDONG LIU，MD, Xiangya Hospital of Central South University
- Investigators
- Wei dong Liu, MD, Principal investigator, Xiangya Hospital of Central South UniversityXi Xie, MD, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498885
- Sponsor's protocol ID
- CCRS-1
- Acronym
- PLAND
- Status last verified
- Sep 2020
- First submitted
- 16 Jan 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we would like to share our data.
Publications
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.
PubMed 22820922Charlson 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.
PubMed 3558716Kim 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.
PubMed 27999945Vermeer 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.
PubMed 24745995Abe 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.
PubMed 28386743Rahbari 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.
PubMed 20004450Smedh 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.
PubMed 27401339Hida 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.
PubMed 10333426Mari 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.
PubMed 25623323Titu LV, Tweedle E, Rooney PS. High tie of the inferior mesenteric artery in curative surgery for left colonic and rectal cancers: a systematic review. Dig Surg. 2008;25(2):148-57. doi: 10.1159/000128172. Epub 2008 Apr 29.
PubMed 18446037Hall 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.
PubMed 7745320Cirocchi 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.
PubMed 22071020Bertrand 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.
PubMed 24633578BERNSTEIN 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.
PubMed 13967713Francone 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.
PubMed 27334448
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03498885
- Acronym / sponsor ID
- PLAND / CCRS-1
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, inferior mesenteric artery, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- WEIDONG LIU，MDUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen.
- Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Procedure： Low ligation with apical lymph node dissection Procedure： High ligation with apical lymph node dissection
| Arm | Type | Receives |
|---|---|---|
| Low ligation | Experimental | Procedure: Low ligationLeft 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 | Procedure: High ligationThe IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 Years to 75 Years (Adult, Senior).
- Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
- Tumor located at 4-15 cm from the dentate line.
- The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
- Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
Key exclusion criteria (17 listed)
- Severe cardiovascular disease, uncontrollable infection or other severe complications.
- Severe mental illness.
- Suffer with other carcinoma simultaneously or sequentially in 5 years.
- Familial polyposis coli or Multiple -colorectal tumor.
- History of abdominal surgery and with severe abdominal adhesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low ligationAlso: LLLeft 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. | Procedure or surgery | Low ligation |
| High ligationAlso: HLThe IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed. | Procedure or surgery | High ligation |
Primary outcome
Anastomotic leakage
Time frame: 3 months
Anastomosis leakage rate after surgery, acute or chronic
14 secondary outcomes
proximal bowel necrosis
Time frame: 3 months
proximal bowel stenosis
Time frame: 3 months
Characteristics of the division branches of the inferior mesenteric artery in Chinese people
Time frame: 1-2 days
Apical Lymph Nodes Positive Rate
Time frame: 14 days
Conversion rate to laparotomy
Time frame: 5-years
Complications of defunctioning stoma
Time frame: 3 months
Early postoperative complications: Anastomotic bleeding, etc.
Time frame: 30 days
Anastomosis stenosis rate after surgery
Time frame: 30 days
Mortality rate in 3 months after surgery
Time frame: 3 months
Life quality
Time frame: 5-years
Micturition function scoring
Time frame: 3 months
Sexual function scoring
Time frame: 3 months
5-years overall survival rate
Time frame: 5-years
5-years disease free survival rate
Time frame: 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 22820922Milnerowicz 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.
- Background: PubMed 3558716Charlson 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.
- Background: PubMed 27999945Kim 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.
- Background: PubMed 24745995Vermeer 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.
- Background: PubMed 28386743Abe 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.
- Background: PubMed 20004450Rahbari 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.
- Background: PubMed 27401339Smedh 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.
- Background: PubMed 10333426Hida 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.
- Background: PubMed 25623323Mari 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.
- Background: PubMed 18446037Titu LV, Tweedle E, Rooney PS. High tie of the inferior mesenteric artery in curative surgery for left colonic and rectal cancers: a systematic review. Dig Surg. 2008;25(2):148-57. doi: 10.1159/000128172. Epub 2008 Apr 29.
- Background: PubMed 7745320Hall 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.
- Background: PubMed 22071020Cirocchi 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.
- Individual participant dataSharing planned: Yes. we would like to share our data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei dong Liu, MD principal investigator
Xiangya Hospital of Central South University
Xi Xie, MD study director
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low ligation and High ligation in people with Rectal Cancer, run by WEIDONG LIU，MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Zou, MD (0086-15874865802, zouting218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498885, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.