SurgerySIMISNCT01844960
Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery
A study testing Single Incision Gastric Band Insertion and Multiple Incision Gastric Band Insertion in people with Surgery and Post-operative Pain, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Post-operative Pain, Post-operative Recovery
- What is being tested?
- Single Incision Gastric Band Insertion and Multiple Incision Gastric Band Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Oct 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbidly obese patients, BMI ≥35 kg/m2
- Undergoing gastric band surgery
- Undergone a pre-weight loss surgery risk assessment
- Fit for anaesthesia and surgery
- Fulfil day surgery criteria
- Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery
Who cannot join
- Pregnancy
- History of portal hypertension
- Previous gastric surgery or large hiatus hernia
- Previous laparotomy or bariatric surgery
- Weight >150kg (day surgery limit)
- Unwilling to consider surgical treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 9RS
About this study
Official title: A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity
A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.
- Conditions
- Surgery, Post-operative Pain, Post-operative Recovery
- Being tested
- Single Incision Gastric Band Insertion, Multiple Incision Gastric Band Insertion
- Keywords
- Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery
- Medical subject headings
- Pain, Postoperative, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Gastric Band InsertionProcedure or surgery
Insertion of gastric band though single abdominal incision
Multiple Incision Gastric Band InsertionProcedure or surgery
Insertion of gastric band though multiple abdominal incisions
| Study group | Role | What they receive |
|---|---|---|
| Multiple Incision Gastric Band Insertion | Active comparator | Current standard surgical approach for laparoscopic gastric band insertion Receives: Procedure: Multiple Incision Gastric Band Insertion |
| Single Incision Gastric Band Insertion | Experimental | New surgical approach for gastric band insertion Receives: Procedure: Single Incision Gastric Band Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: first 10 days post-operatively
Secondary outcomes (1)
Time to Discharge
Measured: Post-operative ward stay (estimated 2-8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameet G Patel, MS FRCS, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844960
- Sponsor's protocol ID
- 11/LO/1592
- Acronym
- SIMIS
- Status last verified
- Apr 2013
- First submitted
- 6 Aug 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Patel AG, Murgatroyd B, Carswell K, Belgaumkar A. Fundus-first transumbilical single-incision laparoscopic cholecystectomy with a cholangiogram: a feasibility study. Surg Endosc. 2011 Mar;25(3):954-7. doi: 10.1007/s00464-010-1240-6. Epub 2010 Aug 19.
PubMed 20721587Patel AG, Belgaumkar AP, James J, Singh UP, Carswell KA, Murgatroyd B. Video. Single-incision laparoscopic left lateral segmentectomy of colorectal liver metastasis. Surg Endosc. 2011 Feb;25(2):649-50. doi: 10.1007/s00464-010-1237-1. Epub 2010 Jul 22.
PubMed 20652322Teixeira J, McGill K, Binenbaum S, Forrester G. Laparoscopic single-site surgery for placement of an adjustable gastric band: initial experience. Surg Endosc. 2009 Jun;23(6):1409-14. doi: 10.1007/s00464-009-0411-9. Epub 2009 Mar 14.
PubMed 19288157de la Torre RA, Satgunam S, Morales MP, Dwyer CL, Scott JS. Transumbilical single-port laparoscopic adjustable gastric band placement with liver suture retractor. Obes Surg. 2009 Dec;19(12):1707-10. doi: 10.1007/s11695-009-9896-5.
PubMed 19579051Nguyen NT, Slone J, Reavis K. Comparison study of conventional laparoscopic gastric banding versus laparoendoscopic single site gastric banding. Surg Obes Relat Dis. 2010 Sep-Oct;6(5):503-7. doi: 10.1016/j.soard.2009.10.001. Epub 2009 Nov 10.
PubMed 19969508Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
PubMed 20174950Patel AG, Murgatroyd B, Ashton WD. Single incision laparoscopic adjustable gastric banding: 111 cases. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):747-51. doi: 10.1016/j.soard.2011.06.013. Epub 2011 Jul 13.
PubMed 21890429
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT01844960
- Acronym / sponsor ID
- SIMIS / 11/LO/1592
- Conditions
- Surgery, Post-operative Pain, Post-operative Recovery
- Keywords
- Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 May 2013 (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.
A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Incision Gastric Band Insertion | Active comparator | Procedure: Multiple Incision Gastric Band InsertionCurrent standard surgical approach for laparoscopic gastric band insertion |
| Single Incision Gastric Band Insertion | Experimental | Procedure: Single Incision Gastric Band InsertionNew surgical approach for gastric band insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Morbidly obese patients, BMI ≥35 kg/m2
- Undergoing gastric band surgery
- Undergone a pre-weight loss surgery risk assessment
- Fit for anaesthesia and surgery
- Fulfil day surgery criteria
Key exclusion criteria (6 listed)
- Pregnancy
- History of portal hypertension
- Previous gastric surgery or large hiatus hernia
- Previous laparotomy or bariatric surgery
- Weight >150kg (day surgery limit)
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 Incision Gastric Band InsertionInsertion of gastric band though single abdominal incision | Procedure or surgery | Single Incision Gastric Band Insertion |
| Multiple Incision Gastric Band InsertionInsertion of gastric band though multiple abdominal incisions | Procedure or surgery | Multiple Incision Gastric Band Insertion |
Primary outcome
Pain
Time frame: first 10 days post-operatively
1 secondary outcome
Time to Discharge
Time frame: Post-operative ward stay (estimated 2-8 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Background: PubMed 20721587Patel AG, Murgatroyd B, Carswell K, Belgaumkar A. Fundus-first transumbilical single-incision laparoscopic cholecystectomy with a cholangiogram: a feasibility study. Surg Endosc. 2011 Mar;25(3):954-7. doi: 10.1007/s00464-010-1240-6. Epub 2010 Aug 19.
- Background: PubMed 20652322Patel AG, Belgaumkar AP, James J, Singh UP, Carswell KA, Murgatroyd B. Video. Single-incision laparoscopic left lateral segmentectomy of colorectal liver metastasis. Surg Endosc. 2011 Feb;25(2):649-50. doi: 10.1007/s00464-010-1237-1. Epub 2010 Jul 22.
- Background: PubMed 19288157Teixeira J, McGill K, Binenbaum S, Forrester G. Laparoscopic single-site surgery for placement of an adjustable gastric band: initial experience. Surg Endosc. 2009 Jun;23(6):1409-14. doi: 10.1007/s00464-009-0411-9. Epub 2009 Mar 14.
- Background: PubMed 19579051de la Torre RA, Satgunam S, Morales MP, Dwyer CL, Scott JS. Transumbilical single-port laparoscopic adjustable gastric band placement with liver suture retractor. Obes Surg. 2009 Dec;19(12):1707-10. doi: 10.1007/s11695-009-9896-5.
- Background: PubMed 19969508Nguyen NT, Slone J, Reavis K. Comparison study of conventional laparoscopic gastric banding versus laparoendoscopic single site gastric banding. Surg Obes Relat Dis. 2010 Sep-Oct;6(5):503-7. doi: 10.1016/j.soard.2009.10.001. Epub 2009 Nov 10.
- Background: PubMed 20174950Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
- Background: PubMed 21890429Patel AG, Murgatroyd B, Ashton WD. Single incision laparoscopic adjustable gastric banding: 111 cases. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):747-51. doi: 10.1016/j.soard.2011.06.013. Epub 2011 Jul 13.
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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.
Ameet G Patel, MS FRCS principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Incision Gastric Band Insertion and Multiple Incision Gastric Band Insertion in people with Surgery and Post-operative Pain, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2015. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: first 10 days post-operatively). 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 NCT01844960, which also lists 7 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 2 Sep 2015.