Colonic PolypsPhase 2/3NCT01101672
Trial for Single Port Versus Conventional Laparoscopic Colectomy
A Phase 2/3 study testing Single port laparoscopic colectomy and Conventional laparoscopic colectomy in people with Colonic Polyps and Colonic Cancers, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colonic Polyps, Colonic Cancers
- What is being tested?
- Single port laparoscopic colectomy and Conventional laparoscopic colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery, Queen Mary Hospital, University of Hong Kong
Hong Kong
Jensen TC Poon, MBBS, 852-22554764, jp@hkma.org
Wai L Law, MBBS, MS, 852=22554763, lawwl@hkucc.hku.hk
About this study
Official title: 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.
Read the 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
- Being tested
- Single port laparoscopic colectomy, Conventional laparoscopic colectomy
- Keywords
- Single port laparoscopic colectomy
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single port laparoscopic colectomyProcedure or surgery
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 colectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-port laparoscopic colectomy | Experimental | Not described Receives: Procedure: Single port laparoscopic colectomy |
| Conventinal laparoscopic colectomy | Active comparator | Not described Receives: Procedure: Conventional laparoscopic colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first three days after operation
Secondary outcomes (4)
Operative blood loss and transfusion
Measured: Immediate peri-operative period
Operative morbidities and 30 days mortality
Measured: 30 days after operation
Length of hospital stay
Measured: Time from operation to discharge
Recurrence and survival for cancer patient
Measured: The expected time frame of follow up is 2 year and 5 five after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wai L Law, MS, MBBS, Study chair, Department of Surgery, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101672
- Sponsor's protocol ID
- UW09-341
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20173474Law 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.
PubMed 19895602
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Outcomes of Patients Who Undergo Single Port Laparoscopic Colectomy and Conventional Laparoscopic Colectomy for Colonic Neoplasia
- ClinicalTrials.gov ID
- NCT01101672
- Acronym / sponsor ID
- UW09-341
- Conditions
- Colonic Polyps, Colonic Cancers
- Keywords
- Single port laparoscopic colectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port laparoscopic colectomy | Experimental | Procedure: Single port laparoscopic colectomy |
| Conventinal laparoscopic colectomy | Active comparator | Procedure: Conventional laparoscopic colectomy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single port laparoscopic colectomyPatients 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 or surgery | Single-port laparoscopic colectomy |
| Conventional laparoscopic colectomyPatient 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. | Procedure or surgery | Conventinal laparoscopic colectomy |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2010.
- Background: PubMed 20173474Law 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.
- Background: PubMed 19895602Law 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai L Law, MS, MBBS study chair
Department of Surgery, University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Single port laparoscopic colectomy and Conventional laparoscopic colectomy in people with Colonic Polyps and Colonic Cancers, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jensen TC Poon, MBBS (852-22554764, jp@hkma.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain on coughing (time frame: The first three days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01101672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2010.