Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-06-28 @ 9:25 PM
Study NCT ID:
NCT04273295
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2020-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 653692, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-14T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First group receives senna-based laxatives . Second group managed by abdominal massage with senna-based laxatives. Evaluation of outcome of two groups as regard to continence and radiological study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'starting dose', 'timeFrame': 'starting dose was assessed at day 0.', 'description': 'the effective starting dose at the begining of treatment.'}, {'measure': 'starting dose', 'timeFrame': 'starting dose was assessed at day 180.', 'description': 'the effective starting dose at the begining of treatment.'}, {'measure': 'end dose', 'timeFrame': 'end dose was assessed at day 0.', 'description': 'the effective ending dose (maintenance dose) at the end of treatment.'}, {'measure': 'end dose', 'timeFrame': 'end dose was assessed at day 180.', 'description': 'the effective ending dose (maintenance dose) at the end of treatment.'}, {'measure': 'time till not soiling', 'timeFrame': 'time till not soiling was assessed at day 0.', 'description': "Stool soiling (encopresis) happens in children who are toilet trained. It's when they accidentally leak feces (poop) into their underwear. Constipation is one of many causes of stool soiling. Other causes include irritable bowel syndrome or when a child is fearful of the bathroom."}, {'measure': 'time till not soiling', 'timeFrame': 'time till not soiling was assessed at day 180.', 'description': "Stool soiling (encopresis) happens in children who are toilet trained. It's when they accidentally leak feces (poop) into their underwear. Constipation is one of many causes of stool soiling. Other causes include irritable bowel syndrome or when a child is fearful of the bathroom."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Constipation', 'Laxatives', 'Massage'], 'conditions': ['Massage']}, 'referencesModule': {'references': [{'pmid': '20548277', 'type': 'BACKGROUND', 'citation': 'Levitt MA, Pena A. Minimally invasive treatment of fecal incontinence and constipation in children. Minerva Chir. 2010 Apr;65(2):223-34.'}, {'pmid': '2870270', 'type': 'BACKGROUND', 'citation': 'Turnbull GK, Lennard-Jones JE, Bartram CI. Failure of rectal expulsion as a cause of constipation: why fibre and laxatives sometimes fail. Lancet. 1986 Apr 5;1(8484):767-9. doi: 10.1016/s0140-6736(86)91783-6.'}, {'pmid': '26825564', 'type': 'BACKGROUND', 'citation': 'Turan N, Ast TA. The Effect of Abdominal Massage on Constipation and Quality of Life. Gastroenterol Nurs. 2016 Jan-Feb;39(1):48-59. doi: 10.1097/SGA.0000000000000202.'}, {'pmid': '21382575', 'type': 'RESULT', 'citation': 'Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.'}, {'pmid': '16678566', 'type': 'RESULT', 'citation': 'Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.'}, {'pmid': '15289770', 'type': 'RESULT', 'citation': 'Voskuijl WP, Heijmans J, Heijmans HS, Taminiau JA, Benninga MA. Use of Rome II criteria in childhood defecation disorders: applicability in clinical and research practice. J Pediatr. 2004 Aug;145(2):213-7. doi: 10.1016/j.jpeds.2004.04.050.'}, {'pmid': '15479678', 'type': 'RESULT', 'citation': 'Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.'}, {'pmid': '18534221', 'type': 'RESULT', 'citation': 'Nurko S, Youssef NN, Sabri M, Langseder A, McGowan J, Cleveland M, Di Lorenzo C. PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial. J Pediatr. 2008 Aug;153(2):254-61, 261.e1. doi: 10.1016/j.jpeds.2008.01.039. Epub 2008 Mar 19.'}, {'pmid': '11986017', 'type': 'RESULT', 'citation': 'Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9. doi: 10.1016/s1091-255x(01)00009-9.'}, {'pmid': '15730338', 'type': 'RESULT', 'citation': 'Weerapong P, Hume PA, Kolt GS. The mechanisms of massage and effects on performance, muscle recovery and injury prevention. Sports Med. 2005;35(3):235-56. doi: 10.2165/00007256-200535030-00004.'}, {'pmid': '21520798', 'type': 'RESULT', 'citation': 'McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.'}, {'pmid': '15895308', 'type': 'RESULT', 'citation': 'Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available.'}, {'pmid': '19217105', 'type': 'RESULT', 'citation': 'Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of abdominal massage with senna-based laxative in managing overflow retentive stool incontinence in pediatrics.', 'detailedDescription': "Much attention has been devoted to children with overflow retentive stool incontinence (ORSI) by the pediatric surgeons, as the referral of such cases from pediatric facilities is constantly increasing. An important initial step in managing these children is the exclusion of Hirschsprung's disease starting by water-soluble contrast enema.\n\nConservative management of ORIS is generally successful. The aim of the treatment is to achieve and maintain regular bowel movements free of symptoms Laxatives remain the mainstay of maintenance therapy of ORSI; yet, there is no standard laxative therapy despite the varieties of medication currently available. New information to these queries can be beneficial to medical staff involved in managing overflow retentive stool incontinence in pediatrics, Possibly it may add new guideline of treatment with more good result , short time and decrease the laxative dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients with ORSI according to Rome III criteria\n* Contrast enema suggestive of fecal loading\n* the absence of anatomic, physiologic or pathologic reason for their constipation\n\nExclusion Criteria:\n\n* radiological suspicion of Hirschsprung's disease,\n* anorectal malformation,\n* mechanical obstruction,\n* failed to comply with the offered treatment (mainly if cramping abdominal pain or vomiting occurred),\n* Required bowel surgery.\n* spina bifida, spinal cord injury,"}, 'identificationModule': {'nctId': 'NCT04273295', 'briefTitle': 'Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'the control group', 'description': 'This group receives senna-based laxatives.'}, {'type': 'EXPERIMENTAL', 'label': 'the study group', 'description': 'This group managed by abdominal massage with senna-based laxatives.', 'interventionNames': ['Other: Abdominal massage']}], 'interventions': [{'name': 'Abdominal massage', 'type': 'OTHER', 'description': 'The patients lying in comfortable relaxed supine position and physiotherapist performed slow circular clockwise movements on the abdomen, throw tangential pushing, with digital pulp, slow and gradual pressure, with fingers inclination 45 degree. The pressure applied to the abdomen on each point for 1 min, beginning with the ascending colon, transverse colon, descending colon and sigmoid; this sequence was repeated approximately 15 min. The therapist teaches the parents this technique and asked them to apply at home 3 times / day for 15 min.', 'armGroupLabels': ['the study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'South Valley University, Faculty of Physical Therapy', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Nehad A. Abo-zaid, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University'}, {'name': 'Nezar A. Abo Halawa, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University'}, {'name': 'Mohammed E. Ali, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Mohammed E. Ali, Ph. D Candidate.', 'investigatorAffiliation': 'South Valley University'}}}}