A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

Overview

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.

Full Title of Study: “A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2020

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.

Interventions

  • 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.
  • 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

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • the operation time
    • Time Frame: up to 36 months

Secondary Measures

  • the total blood loss
    • Time Frame: up to 36 months
  • the number of lymph nodes dissected
    • Time Frame: up to 36 months
  • the average time of ground activities
    • Time Frame: up to 36 months
  • the time to first flatus
    • Time Frame: up to 36 months
  • the intra-operative complication and the post-operative complication
    • Time Frame: up to 36 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Liao-nan Zou,Prof, professor – Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Overall Official(s)
    • Liao-nan Zou, professor, Principal Investigator, GI surgery,Guangdong Province Hospital of Chinese Medicine
    • Jin Wan, PhD, Study Director, GI surgery,Guangdong Province Hospital of Chinese Medicine
  • Overall Contact(s)
    • Liao-nan Zou, MD., 0086-020-13423663496, 13423663496@163.com

Citations Reporting on Results

Zou L, Xiong W, Li H, He Y, Diao D, Zheng Y, Luo L, Tan P, Wang W, Wan J. [Efficacy analysis of laparoscopic radical right hemicolectomy using caudal-to-cranial approach]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Nov;18(11):1124-7. Chinese.

Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12.

Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.