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Trial for Single Port Versus Conventional Laparoscopic Colectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01101672
First received: April 8, 2010
Last updated: April 9, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Colonic Polyps
Colonic Cancers
Procedure: Single port laparoscopic colectomy
Procedure: Conventional laparoscopic colectomy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Outcomes of Patients Who Undergo Single Port Laparoscopic Colectomy and Conventional Laparoscopic Colectomy for Colonic Neoplasia

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Post-operative pain on coughing [ Time Frame: The first three days after operation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Operative blood loss and transfusion [ Time Frame: Immediate peri-operative period ] [ Designated as safety issue: Yes ]
  • Operative morbidities and 30 days mortality [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Time from operation to discharge ] [ Designated as safety issue: No ]
  • Recurrence and survival for cancer patient [ Time Frame: The expected time frame of follow up is 2 year and 5 five after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-port laparoscopic colectomy 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.
Active Comparator: Conventinal laparoscopic colectomy 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101672

Contacts
Contact: Jensen TC Poon, MBBS 852-22554764 jp@hkma.org
Contact: Wai L Law, MBBS, MS 852-22554763 lawwl@hkucc.hku.hk

Locations
Hong Kong
Department of Surgery, Queen Mary Hospital, University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Jensen TC Poon, MBBS    852-22554764    jp@hkma.org   
Contact: Wai L Law, MBBS, MS    852=22554763    lawwl@hkucc.hku.hk   
Principal Investigator: Jensen TC Poon, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Study Chair: Wai L Law, MS, MBBS Department of Surgery, University of Hong Kong
  More Information

Publications:
Responsible Party: Jensen Poon, Department of Surgery, University of Hong Kong
ClinicalTrials.gov Identifier: NCT01101672     History of Changes
Other Study ID Numbers: UW09-341
Study First Received: April 8, 2010
Last Updated: April 9, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Single port laparoscopic colectomy

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Polyps

ClinicalTrials.gov processed this record on November 25, 2014