Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
18 Years
N/A
Both
Pain,, Postoperative Wound Complication
Trial Information
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
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.
Inclusion Criteria:
patients >18 years old and diagnosed to have operable left-sided colorectal cancers distal
to the splenic flexure and proximal to the upper rectum were potential candidates.
Exclusion Criteria:
1. Patient who did not give informed consent;
2. Patient who were considered unfit for operative treatment;
3. Patient presented as acute surgical emergencies, including intestinal obstruction,
peritonitis, or pericolic abscess, etc.;
4. Patients with metastatic diseases on preoperative work up;
5. Patient with synchronous tumours or polyps which necessitate extended or additional
resection;
6. Patients with large bulky tumor as demonstrated on preoperative colonoscopy or
computed tomography showing serosal involvement or invasion to contiguous organs.
7. Patients with anal stenosis that precluded the insertion of TEO device
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
pain score
Outcome Description:
participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week
Outcome Time Frame:
average of 1 week
Safety Issue:
Yes
Principal Investigator
Yui Shan Cheung, FRACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Authority:
Hong Kong: Ethics Committee
Study ID:
HKEC-2009-023
NCT ID:
NCT01762254
Start Date:
June 2009
Completion Date:
June 2012
Related Keywords:
- Pain,
- Postoperative Wound Complication
- pain score
- complication
- Colonic Neoplasms
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