Trial for Single Port Versus Conventional Laparoscopic Colectomy

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01101672
• Other study ID #: UW09-341
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: April 8, 2010
• Last updated: April 9, 2010
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2010
• Source: The University of Hong Kong
• Contact: Jensen TC Poon, MBBS
• Phone: 852-22554764
• Email: jp[@]hkma.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Cancers
• Colonic Neoplasms
• Colonic Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Queen Mary Hospital, University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative blood loss and transfusion		Immediate peri-operative period
Secondary	Operative morbidities and 30 days mortality		30 days after operation
Secondary	Length of hospital stay		Time from operation to discharge
Secondary	Recurrence and survival for cancer patient		The expected time frame of follow up is 2 year and 5 five after operation