Colonic Polyps Clinical Trial
Official title:
A Randomized Controlled Trial Comparing the Outcomes of Patients Who Undergo Single Port Laparoscopic Colectomy and Conventional Laparoscopic Colectomy for Colonic Neoplasia
This study aims to compare the outcomes of patients who undergo single-port laparoscopic
colectomy and conventional laparoscopic colectomy for colonic neoplasia (large polyp not
amenable to endoscopic removal/ cancer) through a randomized controlled trial. After informed
consent, patients will be randomized to have either conventional or single-port laparoscopic
colectomy by a team of surgeons with good experience in laparoscopic colorectal surgery.
Patients' demographic, operative detail and post-operative outcomes including operating time,
blood loss, complications, pain score, analgesic requirement, resumption of gastrointestinal
function and length of hospital stay will be recorded prospectively. The patients will be
blinded to the type of treatment that they have received during the first three days after
operation (post-operative pain and analgesic requirement will be recorded in these period).
Patients will have long term up to record for cancer recurrence and survival.
The results of two groups of patients will be compared scientifically to assess if
single-incision laparoscopic colectomy results in any difference in outcomes when compared to
conventional laparoscopic colectomy.
Status | Unknown status |
Enrollment | 60 |
Est. completion date | October 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: 1. Histologically proven neoplastic disease of colon (large polyps not amenable to endoscopic removal or cancer) 2. Age >18 years 3. Informed consent obtained 4. American Society of Anesthesiologist class 1-3 Exclusion Criteria: 1. Evidence of local invasion on pre-operative imaging 2. Cancer of diameter greater than 5cm 3. Contraindication for laparoscopic surgery 4. Anticipated peritoneal adhesion from previous major abdominal surgery 5. Presence of bowel obstruction 6. Lesion in transverse colon or rectum 7. Anticipated high dependency unit or intensive care unit admission after operation |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Surgery, Queen Mary Hospital, University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Law WL, Fan JK, Poon JT. Single incision laparoscopic left colectomy for carcinoma of distal transverse colon. Colorectal Dis. 2010 Jul;12(7):698-701. doi: 10.1111/j.1463-1318.2009.02114.x. Epub 2009 Nov 6. — View Citation
Law WL, Fan JK, Poon JT. Single-incision laparoscopic colectomy: early experience. Dis Colon Rectum. 2010 Mar;53(3):284-8. doi: 10.1007/DCR.0b013e3181c959ba. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pain on coughing | The patients will be blinded to the type of treatment that they have received during the first three days after operation. During these three days, the post-operative pain score on coughing and analgesic requirement will be recorded independently by the Pain team of Department of Anesthesia who is also blinded to the type of procedure. | The first three days after operation | |
Secondary | Operative blood loss and transfusion | Immediate peri-operative period | ||
Secondary | Operative morbidities and 30 days mortality | 30 days after operation | ||
Secondary | Length of hospital stay | Time from operation to discharge | ||
Secondary | Recurrence and survival for cancer patient | The expected time frame of follow up is 2 year and 5 five after operation |
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