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

NCT ID: NCT02949440

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Ascending Colon Cancer; Ileocaecal Valve Carcinoma; Cancer Flexure Hepatic; Adenocarcinoma of Hepatic Flexure (Diagnosis)

Keywords

Laparoscopic right Hemicolectomy; Caudal-to-cranial Approach

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

the caudal-to-cranial approach

Intervention Type: PROCEDURE

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.

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

Group Type: ACTIVE_COMPARATOR

the medial-to-lateral approach

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Liao-nan Zou,Prof

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liao-nan Zou, professor

Role: PRINCIPAL_INVESTIGATOR

GI surgery,Guangdong Province Hospital of Chinese Medicine

Jin Wan, PhD

Role: STUDY_DIRECTOR

GI surgery,Guangdong Province Hospital of Chinese Medicine

Locations

GI surgery,Guangdong Province Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liao-nan Zou, MD.

Role: CONTACT

Phone: 0086-020-13423663496

Email: 13423663496@163.com

Facility Contacts

liao-nan Zou, MD

Role: primary

xin-quan Lu, MD

Role: backup

References

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.

Reference Type: RESULT

PMID: 26616807 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27072997 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27318491 (View on PubMed)

Other Identifiers

LRHCTC-1

Identifier Type: -

Identifier Source: org_study_id