A Randomized Controlled Trial Comparing the Outcomes of Patients Who Undergo Single Port Laparoscopic Colectomy and Conventional Laparoscopic Colectomy for Colonic Neoplasia
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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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
Wai L Law, MS, MBBS
Department of Surgery, University of Hong Kong
Hong Kong: Ethics Committee