Trial for Single Port Versus Conventional Laparoscopic Colectomy

NCT ID: NCT01101672

Last Updated: 2010-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Colonic Polyps; Colonic Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single-port laparoscopic colectomy

Group Type: EXPERIMENTAL

Single port laparoscopic colectomy

Intervention Type: 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.

Conventinal laparoscopic colectomy

Group Type: ACTIVE_COMPARATOR

Conventional laparoscopic colectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery, University of Hong Kong

Principal Investigators

Wai L Law, MS, MBBS

Role: STUDY_CHAIR

Department of Surgery, University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jensen TC Poon, MBBS

Role: CONTACT

jp@hkma.org

852-22554764

Wai L Law, MBBS, MS

Role: CONTACT

lawwl@hkucc.hku.hk

852-22554763

Facility Contacts

Jensen TC Poon, MBBS

Role: primary

jp@hkma.org

852-22554764

Wai L Law, MBBS, MS

Role: backup

lawwl@hkucc.hku.hk

852=22554763

References

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.

Reference Type: BACKGROUND

PMID: 20173474 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19895602 (View on PubMed)

Other Identifiers

UW09-341

Identifier Type: -

Identifier Source: org_study_id