Laparoscopic surgery with natural orifice extraction 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
This study is testing if a new way of removing cancer from the sigmoid colon or rectum using natural openings in the body is safer and leads to better recovery than traditional laparoscopic surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT02635503 on ClinicalTrials.gov |
What this trial studies
This study compares the safety and efficacy of laparoscopic resection with natural orifice specimen extraction (NOSE) against conventional laparoscopic surgery for patients with sigmoid colon or rectal cancer. It aims to evaluate the inflammatory response and overall outcomes of the two surgical approaches. Participants will undergo either transrectal specimen extraction or standard laparoscopic techniques, with a focus on assessing postoperative recovery and complications. The study is being conducted by the Cancer Institute and Hospital at the Chinese Academy of Medical Sciences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with rectosigmoid adenocarcinoma and specific tumor characteristics.
Not a fit: Patients with a BMI over 30, pregnant or lactating women, and those requiring emergency surgery due to complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgical options and improved recovery for patients with rectosigmoid cancer.
How similar studies have performed: While laparoscopic techniques are well-established, the specific use of natural orifice specimen extraction in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zhixiang Zhou, M.D. — Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
- Study coordinator: Zhixiang Zhou, M.D.
- Email: Dr_zhouzx@163.com
- Phone: +86-139-1123-2981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.