Pain, Clinical Trial
Official title:
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
To compare the two surgical options in their short-term and long term outcomes in the management of early left-sided colorectal cancers. The hypothesis is that the incisionless approach will result in less postoperative pain and wound related complications.
For the left-sided colorectal cancer, the investigators performed colectomy with primary
anatomosis. Currently the investigators have two methods of minimal access approach to the
abdominal cavity in order to complete this operation:
1. Conventional Laparoscopic colectomy The operation is completed by laparoscopic
instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is
abolished and a small wound was created for the delivery of bowel and insertion of
anvil of the circular stapler. Finally, pneumoperitoneum is re-created for
intra-corporeal anastomosis
2. Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the
same manner as conventional laparoscopic colectomy, except that at the end of
procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of
4cm is inserted into the anus for the delivery of specimen and insertion of anvil
instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO
device removed.
These two operations are essentially identical except for the surgical access for the
delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal
Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over
10 years. Large scale studies in the literature have demonstrated the safety and benefits of
laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be
inferior to open approach. With the use of TEO device, the investigators can perform
laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors
and thus it can eliminate the wound-related complications theoretically. In order to find
out which one is a better procedure, the investigators are carrying out a clinical trial to
compare the two surgical options in their short-term and long term outcomes.The results of
this study may have an impact on the care of similar patients in the future.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04680754 -
The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing
|
N/A |