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Trial for Single Port Versus Conventional Laparoscopic Colectomy

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ClinicalTrials.gov Identifier: NCT01101672
Recruitment Status : Unknown
Verified April 2010 by The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : April 12, 2010
Last Update Posted : April 12, 2010
Sponsor:
Information provided by:
The University of Hong Kong

April 8, 2010
April 12, 2010
April 12, 2010
November 2009
July 2011   (Final data collection date for primary outcome measure)
Post-operative pain on coughing [ Time Frame: The first three days after operation ]
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.
Same as current
No Changes Posted
  • Operative blood loss and transfusion [ Time Frame: Immediate peri-operative period ]
  • Operative morbidities and 30 days mortality [ Time Frame: 30 days after operation ]
  • Length of hospital stay [ Time Frame: Time from operation to discharge ]
  • Recurrence and survival for cancer patient [ Time Frame: The expected time frame of follow up is 2 year and 5 five after operation ]
Same as current
Not Provided
Not Provided
 
Trial for Single Port Versus Conventional Laparoscopic Colectomy
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Colonic Polyps
  • Colonic Cancers
  • Procedure: Single port laparoscopic colectomy
    Patients will be operated by using the technique of single port laparoscopic colectomy by surgeon with experiences and training in this procedure. Laparoscopic instruments will be inserted to perform the procedure through a multi-channel single port which is placed via transumbilical incision. The same transumbilical incision will be extended to 3-4cm for extraction of specimen.
  • Procedure: Conventional laparoscopic colectomy
    Patient will be operated by techniques of conventional laparoscopic colectomy. A 10mm subumbilical incision is made for camera port, another 2-4 small incisions (5-10mm in size) will be made for placement of ports and insertion of laparoscopic instrument. A 3-4cm abdominal incision will be made for extraction of specimen.
  • Experimental: Single-port laparoscopic colectomy
    Intervention: Procedure: Single port laparoscopic colectomy
  • Active Comparator: Conventinal laparoscopic colectomy
    Intervention: Procedure: Conventional laparoscopic colectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
October 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 89 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
 
NCT01101672
UW09-341
Yes
Not Provided
Not Provided
Jensen Poon, Department of Surgery, University of Hong Kong
The University of Hong Kong
Not Provided
Study Chair: Wai L Law, MS, MBBS Department of Surgery, University of Hong Kong
The University of Hong Kong
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP