Unique ID issued by UMIN | UMIN000041565 |
---|---|
Receipt number | R000046673 |
Scientific Title | A multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer |
Date of disclosure of the study information | 2020/09/01 |
Last modified on | 2020/08/26 22:22:42 |
A multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer
CONNECT study
A multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer
CONNECT study
Japan |
colon cancer
Gastrointestinal surgery |
Malignancy
NO
To examine the superiority of postoperative hospital stay for intracorporeal anastomosis in comparison to extracorporeal anastomosis.
Others
Comparing the anastomosis times of intracorporeal end-to-end anastomosis and intracorporeal side-to-side anastomosis.
Exploratory
Phase III
length of postoperative stay
time required for anastomosis
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
3
Treatment
Maneuver |
intracorporeal end-to-end anastomosis
intracorporeal side-to-side anastomosis
extracorporeal anastomosis
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients with preoperative histologically diagnosed colon cancer (including adenocarcinoma, squamous cell carcinoma, adenosquamous cell carcinoma, and neuroendocrine tumors)
(2) Patients with tumors in the cecum, ascending colon, transverse colon, descending colon, or sigmoid colon and scheduled for laparoscopic colon resection.
(3) Patients with a maximum tumor diameter of 8 cm or less
(4) Patients with a preoperative clinical diagnosis of Stage I-III
(5) Patients with ECOG Performance Status of grade 0 to 2
(1) Patients who have had a previous colorectal resection
(2) Patients who are scheduled to undergo anastomosis with the Double Stapling Technique
(3) Patients who are scheduled to have a stoma (or who will have a stoma remaining after the operation if it was already in place before the operation)
(4) Patients with bowel obstruction
(5) Patients scheduled to undergo simultaneous resection of multiple organs due to duplicate cancer
(6) Patients scheduled to have more than one anastomosis due to multiple colorectal cancers.
(7) Patients with active intra-abdominal infections
(8) Patients with uncontrolled severe comorbidity
(9) Other patients who are deemed by the attending physician to be unable to participate in the research.
300
1st name | Jun |
Middle name | |
Last name | Watanabe |
Yokohama City University Medical Center
Gastroenterological Center
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa
045-261-5656
jun0926@yokohama-cu.ac.jp
1st name | Shogo |
Middle name | |
Last name | Takei |
Yokohama City University Medical Center
Gastroenterological Center
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa
045-261-5656
shogot@yokohama-cu.ac.jp
Gastroenterological Center, Yokohama City University Medical Center
MEDTRONIC JAPAN CO., LTD.
Profit organization
Clinical Trial Review Committee, Yokohama City University Hospital
3-9 Fukuura, Kanazawa-ku, Yokohama-shi, 236-0004
045-787-2714
chiken@yokohama-cu.ac.jp
NO
横浜市立大学附属市民総合医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横須賀共済病院(神奈川県)
2020 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2020 | Year | 07 | Month | 12 | Day |
2020 | Year | 08 | Month | 25 | Day |
2020 | Year | 09 | Month | 01 | Day |
2028 | Year | 12 | Month | 31 | Day |
2020 | Year | 08 | Month | 26 | Day |
2020 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046673