Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT01844960
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2012-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Conversion to laparoscopic or open surgery', 'timeFrame': 'Intra-operatively'}, {'measure': 'Intraoperative and post-operative complications', 'timeFrame': 'During surgery (intraoperative) and first 30 days (post-operative)'}, {'measure': 'Operative time', 'timeFrame': 'Skin incision to skin closure (estimated 45 -75 minutes)'}, {'measure': 'Cosmesis', 'timeFrame': '6 weeks to 6 months post-operatively'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'first 10 days post-operatively'}], 'secondaryOutcomes': [{'measure': 'Time to Discharge', 'timeFrame': 'Post-operative ward stay (estimated 2-8 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Single Incision Surgery', 'SILS', 'Laparoscopic Gastric Band', 'Morbid Obesity', 'Bariatric Surgery'], 'conditions': ['Surgery', 'Post-operative Pain', 'Post-operative Recovery']}, 'referencesModule': {'references': [{'pmid': '20721587', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20652322', 'type': 'BACKGROUND', 'citation': 'Patel 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.'}, {'pmid': '19288157', 'type': 'BACKGROUND', 'citation': 'Teixeira 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.'}, {'pmid': '19579051', 'type': 'BACKGROUND', 'citation': 'de 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.'}, {'pmid': '19969508', 'type': 'BACKGROUND', 'citation': 'Nguyen 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.'}, {'pmid': '20174950', 'type': 'BACKGROUND', 'citation': 'Tsimoyiannis 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.'}, {'pmid': '21890429', 'type': 'BACKGROUND', 'citation': 'Patel 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbidly obese patients, BMI ≥35 kg/m2\n* Undergoing gastric band surgery\n* Undergone a pre-weight loss surgery risk assessment\n* Fit for anaesthesia and surgery\n* Fulfil day surgery criteria\n* Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* History of portal hypertension\n* Previous gastric surgery or large hiatus hernia\n* Previous laparotomy or bariatric surgery\n* Weight \\>150kg (day surgery limit)\n* Unwilling to consider surgical treatment'}, 'identificationModule': {'nctId': 'NCT01844960', 'acronym': 'SIMIS', 'briefTitle': 'Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity', 'orgStudyIdInfo': {'id': '11/LO/1592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multiple Incision Gastric Band Insertion', 'description': 'Current standard surgical approach for laparoscopic gastric band insertion', 'interventionNames': ['Procedure: Multiple Incision Gastric Band Insertion']}, {'type': 'EXPERIMENTAL', 'label': 'Single Incision Gastric Band Insertion', 'description': 'New surgical approach for gastric band insertion', 'interventionNames': ['Procedure: Single Incision Gastric Band Insertion']}], 'interventions': [{'name': 'Single Incision Gastric Band Insertion', 'type': 'PROCEDURE', 'description': 'Insertion of gastric band though single abdominal incision', 'armGroupLabels': ['Single Incision Gastric Band Insertion']}, {'name': 'Multiple Incision Gastric Band Insertion', 'type': 'PROCEDURE', 'description': 'Insertion of gastric band though multiple abdominal incisions', 'armGroupLabels': ['Multiple Incision Gastric Band Insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ameet G Patel, MS FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}