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The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy

Primary Purpose

Intraoperative Blood Loss, Postoperative Complications, Pathology

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The cranial-caudal mixed medial approach
Sponsored by
Jie Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Blood Loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Subei People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The cranial-caudal mixed medial approach group

the medial approach group

Arm Description

75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.

73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.

Outcomes

Primary Outcome Measures

The operative time
The length of operative time

Secondary Outcome Measures

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.

Full Information

First Posted
June 9, 2023
Last Updated
June 19, 2023
Sponsor
Jie Wang
Collaborators
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05923151
Brief Title
The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy
Official Title
Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Wang
Collaborators
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Blood Loss, Postoperative Complications, Pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The cranial-caudal mixed medial approach group
Arm Type
Experimental
Arm Description
75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.
Arm Title
the medial approach group
Arm Type
Other
Arm Description
73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.
Intervention Type
Procedure
Intervention Name(s)
The cranial-caudal mixed medial approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
The operative time
Description
The length of operative time
Time Frame
Surgery start (skin incision time) - Surgery end (suture incision end time)
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
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.
Time Frame
Surgery start (skin incision time) - Surgery end (suture incision end time)
Other Pre-specified Outcome Measures:
Title
Number of lymph nodes cleaned
Description
Number of lymph node dissection
Time Frame
3-5 days after surgery
Title
Anastomotic leakage
Description
Positive bacterial culture in peritoneal drainage fluid
Time Frame
Within 30 days after surgery
Title
Liver failure
Description
ASL and ALT indicators in liver function examination
Time Frame
Within 30 days after surgery
Title
Renal failure
Description
BUN and Cr indicators in renal function examination
Time Frame
Within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Subei People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy

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