A Phase 3 interventional study of Laparoscopic surgery in Colonic Neoplasms, sponsored by LI XIN-XIANG. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by LI XIN-XIANG · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.
The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.
The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.
The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 1,960 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →LI XIN-XIANG is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Laparoscopic surgery for T4 colon cancers
Procedure: Laparoscopic surgery
Conventional open surgery for T4 colon cancers
Laparoscopic surgery for T4 cancer
Also known as: Laparoscopic surgery for T4 colon cancers
Disease free survival
calculated from the date of surgery to the date of recurrence
Time frame: 3-year
Overall survival
calculated from the date of diagnosis to the date of death from any cause
Time frame: 3-year
Adverse events (mortality and morbidity)
Number of participants with treatment-related adverse events assessed by CTCAE v4.0
Time frame: 3-month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Oct 2016, a primary completion of Oct 2019 and a completion of Oct 2024. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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LI XIN-XIANG