Trial for Single Port Versus Conventional Laparoscopic Colectomy

NCT01101672 | Unknown Phase 2 DMC

• 1 other identifier: UW09-341
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Polyps; Colonic Cancers

Keywords

Single port laparoscopic colectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative blood loss and transfusion

  Immediate peri-operative period

• Operative morbidities and 30 days mortality

  30 days after operation

• Length of hospital stay

  Time from operation to discharge

• Recurrence and survival for cancer patient

  The expected time frame of follow up is 2 year and 5 five after operation

Study Arms (2)

Single-port laparoscopic colectomy

EXPERIMENTAL

Procedure: Single port laparoscopic colectomy

Conventinal laparoscopic colectomy

ACTIVE COMPARATOR

Procedure: Conventional laparoscopic colectomy

Interventions

Single port laparoscopic colectomy PROCEDURE

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.

Single-port laparoscopic colectomy

Conventional laparoscopic colectomy PROCEDURE

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.

Conventinal laparoscopic colectomy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven neoplastic disease of colon (large polyps not amenable to endoscopic removal or cancer)
• Age \>18 years
• Informed consent obtained
• American Society of Anesthesiologist class 1-3

You may not qualify if:

• Evidence of local invasion on pre-operative imaging
• Cancer of diameter greater than 5cm
• Contraindication for laparoscopic surgery
• Anticipated peritoneal adhesion from previous major abdominal surgery
• Presence of bowel obstruction
• Lesion in transverse colon or rectum
• Anticipated high dependency unit or intensive care unit admission after operation

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

• 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.

  PMID: 20173474 BACKGROUND

• 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.

  PMID: 19895602 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Wai L Law, MS, MBBS

  Department of Surgery, University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Jensen TC Poon, MBBS

CONTACT

852-22554764; jp@hkma.org

Wai L Law, MBBS, MS

CONTACT

852-22554763; lawwl@hkucc.hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

HK (1)