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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02635503
Enrollment
366
Registered
2015-12-21
Start date
2015-11-30
Completion date
2025-12-31
Last updated
2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, laparoscopic surgery, natural orifice specimen extraction, Inflammatory response

Brief 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.

Detailed description

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

Interventions

PROCEDUREtransrectal 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.

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.

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 Ⅰ-Ⅲ * 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

Design outcomes

Primary

MeasureTime frameDescription
Early morbidity rate30 daysThe early morbidity rate is defined as the event observed during operation and within 30 days after surgery.

Secondary

MeasureTime frameDescription
Peritoneal bacterial contamination1 dayPeritoneal 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 score14 daysRecording of the needed analgesia guided by pain score
Duration of the intervention1 dayDuration of surgery.
5-year overall survival rate5 yearsA 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 surgery7 daysWe have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
3-year disease free survival rate3 yearsA 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.

Countries

China

Contacts

Primary ContactZhixiang Zhou, M.D.
Dr_zhouzx@163.com+86-139-1123-2981
Backup ContactJianwei Liang, M.D.
liangjw1976@126.com+86-130-7119-7461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026