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Completed

NCT Number: NCT05923151

The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Subei People's Hospital

Yangzhou, Jiangsu, 225000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The cranial-caudal mixed medial approach

Procedure

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 outcomes

  1. The operative time

    Time frame: Surgery start (skin incision time) - Surgery end (suture incision end time)

    The length of operative time

Secondary outcomes

  1. 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.

Other outcomes

  1. Number of lymph nodes cleaned

    Time frame: 3-5 days after surgery

    Number of lymph node dissection

  2. Anastomotic leakage

    Time frame: Within 30 days after surgery

    Positive bacterial culture in peritoneal drainage fluid

  3. Liver failure

    Time frame: Within 30 days after surgery

    ASL and ALT indicators in liver function examination

  4. Renal failure

    Time frame: Within 30 days after surgery

    BUN and Cr indicators in renal function examination

Sponsors and collaborators

Lead sponsor

Jie Wang

Other

Collaborators

  • Yangzhou University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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