- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05923151
The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy
Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225000
- Subei People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The cranial-caudal mixed medial approach group
75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.
|
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.
|
|
Other: the medial approach group
73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The operative time
Time Frame: Surgery start (skin incision time) - Surgery end (suture incision end time)
|
The length of operative time
|
Surgery start (skin incision time) - Surgery end (suture incision end time)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative blood loss
Time Frame: Surgery start (skin incision time) - Surgery end (suture incision end time)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of lymph nodes cleaned
Time Frame: 3-5 days after surgery
|
Number of lymph node dissection
|
3-5 days after surgery
|
|
Anastomotic leakage
Time Frame: Within 30 days after surgery
|
Positive bacterial culture in peritoneal drainage fluid
|
Within 30 days after surgery
|
|
Liver failure
Time Frame: Within 30 days after surgery
|
ASL and ALT indicators in liver function examination
|
Within 30 days after surgery
|
|
Renal failure
Time Frame: Within 30 days after surgery
|
BUN and Cr indicators in renal function examination
|
Within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SubeiH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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