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.
Conventionally laparoscopic surgery requires multiple abdominal wall incision for placement
of ports and laparoscopic instrument to perform the operation. With the advancement of
technology, laparoscopic surgery can now be performed through one special port which can
accommodate several laparoscopic instruments to perform the operation and hence, require only
one small 2-3cm incision through the umbilicus. This is commonly named as Single-incision
Laparoscopic Surgery (SILS) or single-port laparoscopic surgery.
Compared to conventional laparoscopic surgery, SILS has the advantage of further reduction of
post-operative wound pain because of only one small abdominal incision is required. The
cosmetic result from SILS is also better because the only incision is made through the
umbilicus which can hide the wound effectively after operation. After complete healing of the
umbilical wound, the patient's abdomen could be visually 'scarless'.
There has been no study to compare the results of the new single-port laparoscopic colectomy
to the conventional laparoscopic colectomy in the literature yet. In order to decide if this
new technique should be recommended to more patients for treatment of colonic neoplasia, a
formal study is required. We designed a patient blinded randomized controlled trial to
investigate if there is any difference between these two laparoscopic colectomies.
The primary outcome to be measured is post-operative pain on coughing and analgesia
consumption. 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 and analgesic requirement will be recorded independently by the Pain team who is also
blinded to the type of procedure.
The secondary to be measured include operating time, blood loss, morbidities and mortality,
cancer recurrence and patient survival in long term. The secondary outcomes will also be
recorded prospectively and compared.
Definition of conversion:
Conversion to conventional is defined as the need to place additional port to aid the
procedure during the single port laparoscopic colectomy Conversion to open is defined as(1)
the need to perform conventional laparotomy in order to accomplish the procedure or (2)
premature abdominal incision for colorectal dissection or vascular control during single port
or conventional laparoscopic colectomy.
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