Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02635503|
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: transrectal specimen extraction Procedure: Conventional laparoscopic surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2025|
Experimental: transrectal specimen extraction
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
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.
Other Name: NOSE
Active Comparator: Conventional laparoscopic surgery
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Procedure: 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.
Other Name: CLS
- Early morbidity rate [ Time Frame: 30 days ]The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
- Duration of the intervention [ Time Frame: 1 day ]Duration of surgery.
- Peritoneal bacterial contamination [ Time Frame: 1 day ]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.
- Pain score [ Time Frame: 14 days ]Recording of the needed analgesia guided by pain score
- 3-year disease free survival rate [ Time Frame: 3 years ]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-year overall survival rate [ Time Frame: 5 years ]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.
- Plasma levels of several cytokines after colorectal cancer surgery [ Time Frame: 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635503
|Contact: Zhixiang Zhou, M.D.||+86-139-1123-2981||Dr_zhouzx@163.com|
|Contact: Jianwei Liang, M.D.||+firstname.lastname@example.org|
|Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Jianwei Liang, M.D. +86-130-7119-7461 email@example.com|
|Contact: Zhixiang Zhou, M.D. +86-139-1123-2981 Dr_zhouzx@163.com|
|Principal Investigator: Zhixiang Zhou, M.D.|
|Principal Investigator:||Zhixiang Zhou, M.D.||Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College|