Clinical trial NCT02949440: A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
Official title: A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ascending Colon Cancer
Ileocaecal Valve Carcinoma
Cancer Flexure Hepatic
Adenocarcinoma of Hepatic Flexure (Diagnosis)
Keywords: Laparoscopic right Hemicolectomy
Caudal-to-cranial Approach
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the operation time
timeFrame: up to 36 months
Secondary outcomes:
measure: the total blood loss
timeFrame: up to 36 months
measure: the number of lymph nodes dissected
timeFrame: up to 36 months
measure: the average time of ground activities
timeFrame: up to 36 months
measure: the time to first flatus
timeFrame: up to 36 months
measure: the intra-operative complication and the post-operative complication
timeFrame: up to 36 months
Other outcomes:
measure: the 3-year and 5-year Disease-free survival（DFS）
timeFrame: up to 3 years and 5 years
measure: 3-year and 5-year Overall survival（OS）
timeFrame: up to 3 years and 5 years
Locations:
city: Guangzhou
country: China
facility: GI surgery,Guangdong Province Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: GI surgery,Guangdong Province Hospital of Chinese Medicine
name: Liao-nan Zou, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: GI surgery,Guangdong Province Hospital of Chinese Medicine
name: Jin Wan, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.