Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

A Randomized Controlled Trial of Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to elucidate whether there is a difference in long-term prognosis between laparoscopic surgery and open surgery in colon cancer patients with visceral obesity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;

• Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;

• Tumor lower edge \> 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;

• Single primary lesion;

• Aged 18 (inclusive) to 75 (inclusive) years;

• Clinical stage T3/4Nany or T1-4N+ on chest non-contrast CT and abdominal enhanced CT, no distant metastasis, and resectable as judged by the surgeon;

• Treatment-naive, no prior anti-tumor treatment;

• Completed blood routine, liver and kidney function tests, carcinoembryonic antigen (CEA), and carbohydrate antigen 199 (CA199) before randomization, with American Society of Anesthesiologists (ASA) score ≤ III;

• Patient able to understand the study protocol and willing to participate in the study.

Locations
Other Locations
China
Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jun Li, M.D.
2307016@zju.edu.cn; lj6088@gmail.com
+86 13777878061
Backup
YuRong Jiao
jiaoyurong@zju.edu.cn
+86 13732206364
Time Frame
Start Date: 2026-01-18
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 664
Treatments
Active_comparator: Laparoscopic Surgery Group
The abdominal cavity is insufflated to establish a pneumoperitoneum for surgical exposure, and laparoscopic surgery is initiated by inserting the laparoscope through a trocar site into the peritoneal cavity.~Laparoscopic intracorporeal anastomosis is feasible. The specimen must be retrieved through an abdominal wall incision. The dissection sequence is determined by the surgeon's preference.
Experimental: Open Surgery Group
Open surgery involves making an abdominal incision to dissect through the skin, subcutaneous tissue, fascia, and muscle, thereby accessing the peritoneal cavity and enabling direct manual manipulation of intra-abdominal organs for surgical intervention.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov