NCT05923151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

5.4 years

First QC Date

June 9, 2023

Last Update Submit

June 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The operative time

    The length of operative time

    Surgery start (skin incision time) - Surgery end (suture incision end time)

Secondary Outcomes (1)

  • Intraoperative blood loss

    Surgery start (skin incision time) - Surgery end (suture incision end time)

Other Outcomes (4)

  • Number of lymph nodes cleaned

    3-5 days after surgery

  • Anastomotic leakage

    Within 30 days after surgery

  • Liver failure

    Within 30 days after surgery

  • +1 more other outcomes

Study Arms (2)

The cranial-caudal mixed medial approach group

EXPERIMENTAL

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

the medial approach group

OTHER

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

Interventions

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.

The cranial-caudal mixed medial approach groupthe medial approach group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: 18-70 years old
  • Right colon cancer confirmed by colonoscopy and pathological diagnosis
  • Single primary tumor without distal metastasis
  • Laparoscopic operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Subei People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 28, 2023

Study Start

February 1, 2017

Primary Completion

June 30, 2022

Study Completion

February 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations