The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy

Sponsor
Jie Wang (Other)
Overall Status
Completed
CT.gov ID
NCT05923151
Collaborator
Yangzhou University (Other)
148
1
2
72
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: The cranial-caudal mixed medial approach
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Feb 1, 2023

Arms and Interventions

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. The operative time [Surgery start (skin incision time) - Surgery end (suture incision end time)]

    The length of operative time

Secondary Outcome Measures

  1. Intraoperative blood loss [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.

Other Outcome Measures

  1. Number of lymph nodes cleaned [3-5 days after surgery]

    Number of lymph node dissection

  2. Anastomotic leakage [Within 30 days after surgery]

    Positive bacterial culture in peritoneal drainage fluid

  3. Liver failure [Within 30 days after surgery]

    ASL and ALT indicators in liver function examination

  4. Renal failure [Within 30 days after surgery]

    BUN and Cr indicators in renal function examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Subei People's Hospital Yangzhou Jiangsu China 225000

Sponsors and Collaborators

  • Jie Wang
  • Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Wang, Principal Investigator, Subei People's Hospital of Jiangsu Province
ClinicalTrials.gov Identifier:
NCT05923151
Other Study ID Numbers:
  • SubeiH
First Posted:
Jun 28, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2023