Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) fo… (NCT02635503) | Clinical Trial Compass
UnknownPhase 3
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
China366 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 â… -â…¢
* 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
What they're measuring
1
Early morbidity rate
Timeframe: 30 days
Trial details
NCT IDNCT02635503
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences