Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559087
• Other study ID #: WA2020RW12
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 2022

Study information

• Verified date: September 2020
• Source: Zunyi Medical College
• Contact: Fujian Xu, Master
• Phone: +8615895864837
• Email: 911583440[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radical surgery for rectal cancer has evolved from the initial concept of total mesorctal excision (TME) to the wide application of laparoscopic surgery in the radical treatment of rectal cancer. After 30 years' rapid development, nowdays laparoscopic TME surgery for rectal cancer has become the first choice for those patients with rectal cancer. However, the auxiliary incision of the abdominal wall which is used to remove tumor specimens is contrary to the current concept of minimally invasive surgery. Avoiding abdominal wall incisions has become a common appeal of gastrointestinal surgeons and patients with rectal cancer. Natural orififice specimen extraction surgery (NOSES) can solve the problem of abdominal wall auxiliary incision, which complete rectal cancer radical resection and gastrointestinal reconstruction under the full laparoscopic. The specimens are taken out through the natural orifice (rectum or vagina) without an auxiliary incision, which is more in line with minimally invasive practice and easier to operate. Researching on the progress of laparoscopic radical resection of rectal cancer in NOSES aims to provide a certain reference for this operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (=T3); (4) tumor circumference <5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.

Exclusion Criteria:

• The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) > 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score = IV; (7) active period of infection; (8) blood neutrophils <3 × 109/L.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Laparoscopic Surgery
NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes. Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall.

Locations

Country	Name	City	State
China	Affiliated hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	pulmonary infection,Urinary tract infection,anal function,intestinal obstruction,Anastomotic bleeding,etc.	One month after operation
Secondary	survival	3-year and 5-year Overall survival rate	3-year and 5-year after operation