Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

Colorectal Cancer Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635503
• Other study ID #: NCC2015SF-04
• Status: Recruiting
• Phase: Phase 3
• First received: November 30, 2015
• Last updated: September 1, 2016
• Start date: November 2015
• Est. completion date: December 2025

Study information

• Verified date: September 2016
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Zhixiang Zhou, M.D.
• Phone: +86-139-1123-2981
• Email: Dr_zhouzx[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Description:

Further study details as provided by Chinese Academy of Medical Sciences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years < age < 80 years

• Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)

• Pathological rectosigmoid adenocarcinoma

• Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual

• Tumor size of 6 cm or less;

• Eastern Cooperative Oncology Group (ECOG) score is 0-1

• American Society of Anesthesiology (ASA) score is ?-?

• Informed consent

Exclusion Criteria:

• Body mass index (BMI) >30 kg/m2

• Pregnant woman or lactating woman

• Severe mental disease

• Previous abdominal surgery

• Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer

• Requirement of simultaneous surgery for other disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• transrectal specimen extraction
After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
• Conventional laparoscopic surgery
High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early morbidity rate	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.	30 days	Yes
Secondary	Duration of the intervention	Duration of surgery.	1 day	Yes
Secondary	Peritoneal bacterial contamination	Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.	1 day	No
Secondary	Pain score	Recording of the needed analgesia guided by pain score	14 days	No
Secondary	3-year disease free survival rate	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.	3 years	No
Secondary	5-year overall survival rate	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.	5 years	No
Secondary	Plasma levels of several cytokines after colorectal cancer surgery	We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.	7 days	No