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A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach (LRHCTC-1)

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ClinicalTrials.gov Identifier: NCT02949440
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Liao-nan Zou,Prof, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

Condition or disease Intervention/treatment Phase
Ascending Colon Cancer Ileocaecal Valve Carcinoma Cancer Flexure Hepatic Adenocarcinoma of Hepatic Flexure (Diagnosis) Procedure: the caudal-to-cranial approach Procedure: the medial-to-lateral approach Not Applicable

Detailed Description:

To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.

A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size,150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time,The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication,and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate(OS)at 3 years and 5 years.The data in two groups will be compared.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
Study Start Date : October 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: the caudal-to-cranial approach
Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein(SMV)and Superior mesenteric artery(SMA)and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein(SMV). In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called caudal-to-cranial approach.
Procedure: the caudal-to-cranial approach
Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach.

Active Comparator: the medial-to-lateral approach
First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein(SMV)to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach
Procedure: the medial-to-lateral approach
First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach




Primary Outcome Measures :
  1. the operation time [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. the total blood loss [ Time Frame: up to 36 months ]
  2. the number of lymph nodes dissected [ Time Frame: up to 36 months ]
  3. the average time of ground activities [ Time Frame: up to 36 months ]
  4. the time to first flatus [ Time Frame: up to 36 months ]
  5. the intra-operative complication and the post-operative complication [ Time Frame: up to 36 months ]

Other Outcome Measures:
  1. the 3-year and 5-year Disease-free survival(DFS) [ Time Frame: up to 3 years and 5 years ]
  2. 3-year and 5-year Overall survival(OS) [ Time Frame: up to 3 years and 5 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The age limits is 18-80 years old;
  2. The clinical staging was II,III carcinoma of right colon,located in right-sided colon;
  3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
  4. American Society of anesthesiologists (ASA) score less than or equal to Level III;
  5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

  1. The patients' age limits is Less than 18 years old, or more than 80 years old
  2. The preoperative imaging confirmed that the tumor involve adjacent organs;
  3. The tumor have been finding distant metastases;
  4. American Society of anesthesiologists (ASA) score more than 3;
  5. Criteria of performance status karnofsky is lower than 60;
  6. It is the carcinoma of right colon with multiple colonic polyps Disease;
  7. there is a laparoscopic surgery contraindications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949440


Contacts
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Contact: Liao-nan Zou, MD. 0086-020-13423663496 13423663496@163.com

Locations
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China, Guangdong
GI surgery,Guangdong Province Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: liao-nan Zou, MD    0086-020-13423663496    13423663496@163.com   
Contact: xin-quan Lu, MD    0086-020-18898607919    18898607919@163.com   
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Liao-nan Zou, professor GI surgery,Guangdong Province Hospital of Chinese Medicine
Study Director: Jin Wan, PhD GI surgery,Guangdong Province Hospital of Chinese Medicine

Publications of Results:
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Responsible Party: Liao-nan Zou,Prof, professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02949440     History of Changes
Other Study ID Numbers: LRHCTC-1
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Liao-nan Zou,Prof, Guangdong Provincial Hospital of Traditional Chinese Medicine:
Laparoscopic right Hemicolectomy
Caudal-to-cranial Approach
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms