The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy

Postoperative Complications Clinical Trial

Official title:

Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05923151
• Other study ID #: SubeiH
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: Subei People's Hospital of Jiangsu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. Laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of intraoperative bleeding, and has good clinical results.

Description:

The data of patients undergoing laparoscopic right hemicolectomy performed in the same surgical group of gastrointestinal surgery at Northern Jiangsu People's Hospital from February 2017 to June 2022 were retrospectively analyzed. According to different surgical approaches, patients were divided into the cranial-caudal mixed medial approach group and the medial approach group.

Intraoperative and postoperative data were collected. Intraoperative data is obtained through surgical records and pathological reports, including total operation time, Laparoscopic procedure time, Intraoperative blood loss, sample length, number of lymph nodes collected, and number of positive lymph nodes. Postoperative data includes exhaust time, liquid intake time, postoperative hospitalization and complications. Among them, complications are short-term postoperative complications (surgical related complications, non-surgical related complications) within the first 30 days after surgery (or throughout the hospitalization period, if more than 30 days, and are classified according to the Clavien-Dindo classification method.

To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age range: 18-70 years old

• Right colon cancer confirmed by colonoscopy and pathological diagnosis

• Single primary tumor without distal metastasis

• Laparoscopic operation

Exclusion Criteria:

• Age below 18 and above 70 years old

• Patients who need urgent surgery

• Persons with a history of malignant tumors

• Multiple primary tumors or distant metastases

Related Conditions & MeSH terms

• Intraoperative Blood Loss
• Pathology
• Postoperative Complications

Intervention

Procedure:
• The cranial-caudal mixed medial approach
Expose the fusion fascia of Transverse colon mesocolon and stomach, and cut the gastrocolic ligament. The mesentery of Transverse colon was dissociated from the medial side to the lateral side along the gastroepiploic vessels to expose the branches of Henle's trunk and the right colon vessels. The dorsal mesentery of the small intestine is cut along the "yellow white line", and free cephalically along the Toldt space to separate the posterior space of the Ascending colon and the anterior space of the pancreas and duodenum behind the Transverse colon. The right colon blood vessels were dissected along SMV from the projection of ileocolic blood vessels, and the blood vessels were cut off by high ligation, and the lymph nodes at the root of Mesentery were cleared. Through a small incision in the middle of the abdomen, the right colon and mesentery were completely removed to complete digestive tract reconstruction.

Locations

Country	Name	City	State
China	Subei People's Hospital	Yangzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jie Wang	Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of lymph nodes cleaned	Number of lymph node dissection	3-5 days after surgery
Other	Anastomotic leakage	Positive bacterial culture in peritoneal drainage fluid	Within 30 days after surgery
Other	Liver failure	ASL and ALT indicators in liver function examination	Within 30 days after surgery
Other	Renal failure	BUN and Cr indicators in renal function examination	Within 30 days after surgery
Primary	The operative time	The length of operative time	Surgery start (skin incision time) - Surgery end (suture incision end time)
Secondary	Intraoperative blood loss	Measurement by gauze transfusion weighing method: soaked 32cm × A 20cm sized gauze loses approximately 30ml of blood; Soak 36cm × A 36cm sized gauze loses approximately 50ml of blood.	Surgery start (skin incision time) - Surgery end (suture incision end time)