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

Not Applicable

Recruiting

• Conditions: Ileocaecal Valve Carcinoma; Cancer Flexure Hepatic; Ascending Colon Cancer; Adenocarcinoma of Hepatic Flexure (Diagnosis)
• Interventions: Procedure: the caudal-to-cranial approach; Procedure: the medial-to-lateral approach

• Registration Number: NCT02949440
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-28
• Study First Posted: 2016-10-31
• Last Update Posted: 2016-10-31
• Primary Completion: 2020-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the caudal-to-cranial approach	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.
the medial-to-lateral 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

Primary Outcome Measures

Name	Time	Method
the operation time	up to 36 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GI surgery,Guangdong Province Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China