Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers
NCT ID: NCT03260647
Last Updated: 2025-06-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
96 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-08-04
Study Completion Date
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)
NCT03580421
Endometrial Cancer Stage I
Endometrial Cancer Stage II
COMPLETED
NA
Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.
NCT02598219
Non Endometrioid Carcinoma
Endometrioid Carcinoma
ACTIVE_NOT_RECRUITING
PHASE3
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
NCT07267780
Ovarian Carcinoma
Cervical Carcinoma
Endometrial Carcinoma
+3 more
NOT_YET_RECRUITING
A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy
NCT02463877
Cancer
COMPLETED
PHASE2
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
NCT06071507
Gastric Outlet Obstruction
Pancreatic Cancer
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Guidelines for the management of patients with Malignant Bowel Obstruction(MBO) are not available and as such, there remains an urgent need for a collaborative approach to streamline patient care and optimize use of hospital resources. This study will focus on management of MBO in advanced gynecological cancers.If patients with MBO can be effectively managed in an ambulatory setting, this may improve quality and consistency of patient care, and help reduce volume and duration of bed occupancy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Gynecologic Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Management algorithm for Malignant Bowel Obstruction
a proposed management algorithm for MBO has been developed to provide a pathway that safeguards quality and continuity of care for patients under a multidisciplinary team. It will engage key-stakeholders and foster an inter-professional approach. It incorporates an in-patient management algorithm and a novel nursing-led ambulatory management algorithm to supplement patient's medical management
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Histologically and /or cytologically confirmed gynecological cancer, including ovarian, fallopian tube, endometrial, cervical or primary peritoneal cancer Deemed to be at risk of developing or have a clinical diagnosis of MBO as defined using the following criteria: clinical evidence of bowel obstruction (history/physical/radiological examination; and bowel obstruction beyond the ligament of Treitz.
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie Lheureux
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Tran E, Spiceland C, Sandhu NP, Jatoi A. Malignant Bowel Obstruction in Patients With Recurrent Ovarian Cancer. Am J Hosp Palliat Care. 2016 Apr;33(3):272-5. doi: 10.1177/1049909114566225. Epub 2014 Dec 31.
Reference Type
BACKGROUND
Mooney SJ, Winner M, Hershman DL, Wright JD, Feingold DL, Allendorf JD, Neugut AI. Bowel obstruction in elderly ovarian cancer patients: a population-based study. Gynecol Oncol. 2013 Apr;129(1):107-12. doi: 10.1016/j.ygyno.2012.12.028. Epub 2012 Dec 26.
Reference Type
BACKGROUND
Sartori E, Chiudinelli F, Pasinetti B, Maggino T. Bowel obstruction and survival in patients with advanced ovarian cancer: analysis of prognostic variables. Int J Gynecol Cancer. 2009 Jan;19(1):54-7. doi: 10.1111/IGC.0b013e318198ff4b. No abstract available.
Reference Type
BACKGROUND
Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014 Oct 11;384(9951):1376-88. doi: 10.1016/S0140-6736(13)62146-7. Epub 2014 Apr 21.
Reference Type
BACKGROUND
Martin-Lorente C, Mackay H, Lafromboise L, et al: Retrospective review of malignant bowel obstruction (MBO) outcomes in patients with epithelial ovarian carcinoma (EOC), International Journal of Gynecological Cancer, 2015, pp 1434-1435
Reference Type
BACKGROUND
Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4.
Reference Type
BACKGROUND
Ripamonti C, Twycross R, Baines M, Bozzetti F, Capri S, De Conno F, Gemlo B, Hunt TM, Krebs HB, Mercadante S, Schaerer R, Wilkinson P; Working Group of the European Association for Palliative Care. Clinical-practice recommendations for the management of bowel obstruction in patients with end-stage cancer. Support Care Cancer. 2001 Jun;9(4):223-33. doi: 10.1007/s005200000198.
Reference Type
BACKGROUND
Tuca A, Guell E, Martinez-Losada E, Codorniu N. Malignant bowel obstruction in advanced cancer patients: epidemiology, management, and factors influencing spontaneous resolution. Cancer Manag Res. 2012;4:159-69. doi: 10.2147/CMAR.S29297. Epub 2012 Jun 13.
Reference Type
BACKGROUND
Daniele A, Ferrero A, Fuso L, Mineccia M, Porcellana V, Vassallo D, Biglia N, Menato G. Palliative care in patients with ovarian cancer and bowel obstruction. Support Care Cancer. 2015 Nov;23(11):3157-63. doi: 10.1007/s00520-015-2694-9. Epub 2015 Mar 25.
Reference Type
BACKGROUND
Ripamonti CI, Easson AM, Gerdes H. Management of malignant bowel obstruction. Eur J Cancer. 2008 May;44(8):1105-15. doi: 10.1016/j.ejca.2008.02.028. Epub 2008 Mar 21.
Reference Type
BACKGROUND
Cousins SE, Tempest E, Feuer DJ. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2016 Jan 4;2016(1):CD002764. doi: 10.1002/14651858.CD002764.pub2.
Reference Type
BACKGROUND
Feuer DJ, Broadley KE, Shepherd JH, Barton DP. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2000;(4):CD002764. doi: 10.1002/14651858.CD002764.
Reference Type
BACKGROUND
Furnes B, Svensen R, Helland H, Ovrebo K. Challenges and outcome of surgery for bowel obstruction in women with gynaecologic cancer. Int J Surg. 2016 Mar;27:158-164. doi: 10.1016/j.ijsu.2016.02.002. Epub 2016 Feb 4.
Reference Type
BACKGROUND
Levy M, Smith T, Alvarez-Perez A, Back A, Baker JN, Beck AC, Block S, Dalal S, Dans M, Fitch TR, Kapo J, Kutner JS, Kvale E, Misra S, Mitchell W, Portman DG, Sauer TM, Spiegel D, Sutton L, Szmuilowicz E, Taylor RM, Temel J, Tickoo R, Urba SG, Weinstein E, Zachariah F, Bergman MA, Scavone JL. Palliative Care Version 1.2016. J Natl Compr Canc Netw. 2016 Jan;14(1):82-113. doi: 10.6004/jnccn.2016.0009.
Reference Type
BACKGROUND
Kolomainen DF, Daponte A, Barton DP, Pennert K, Ind TE, Bridges JE, Shepherd JH, Gore ME, Kaye SB, Riley J. Outcomes of surgical management of bowel obstruction in relapsed epithelial ovarian cancer (EOC). Gynecol Oncol. 2012 Apr;125(1):31-6. doi: 10.1016/j.ygyno.2011.11.007. Epub 2011 Nov 12.
Reference Type
BACKGROUND
Mangili G, Aletti G, Frigerio L, Franchi M, Panacci N, Vigano R, DE Marzi P, Zanetto F, Ferrari A. Palliative care for intestinal obstruction in recurrent ovarian cancer: a multivariate analysis. Int J Gynecol Cancer. 2005 Sep-Oct;15(5):830-5. doi: 10.1111/j.1525-1438.2005.00144.x.
Reference Type
BACKGROUND
Goto T, Takano M, Aoyama T, Miyamoto M, Watanabe A, Kato M, Sasaki N, Hirata J, Sasa H, Furuya K. Outcomes of palliative bowel surgery for malignant bowel obstruction in patients with gynecological malignancy. Oncol Lett. 2012 Nov;4(5):883-888. doi: 10.3892/ol.2012.835. Epub 2012 Jul 30.
Reference Type
BACKGROUND
Kucukmetin A, Naik R, Galaal K, Bryant A, Dickinson HO. Palliative surgery versus medical management for bowel obstruction in ovarian cancer. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007792. doi: 10.1002/14651858.CD007792.pub2.
Reference Type
BACKGROUND
Bryan DN, Radbod R, Berek JS. An analysis of surgical versus chemotherapeutic intervention for the management of intestinal obstruction in advanced ovarian cancer. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):125-34. doi: 10.1111/j.1525-1438.2006.00283.x.
Reference Type
BACKGROUND
Diver E, O'Connor O, Garrett L, Boruta D, Goodman A, Del Carmen M, Schorge J, Mueller P, Growdon W. Modest benefit of total parenteral nutrition and chemotherapy after venting gastrostomy tube placement. Gynecol Oncol. 2013 May;129(2):332-5. doi: 10.1016/j.ygyno.2013.02.002. Epub 2013 Feb 8.
Reference Type
BACKGROUND
Chouhan J, Gupta R, Ensor J, Raghav K, Fogelman D, Wolff RA, Fisch M, Overman MJ. Retrospective analysis of systemic chemotherapy and total parenteral nutrition for the treatment of malignant small bowel obstruction. Cancer Med. 2016 Feb;5(2):239-47. doi: 10.1002/cam4.587. Epub 2015 Dec 29.
Reference Type
BACKGROUND
Abu-Rustum NR, Barakat RR, Venkatraman E, Spriggs D. Chemotherapy and total parenteral nutrition for advanced ovarian cancer with bowel obstruction. Gynecol Oncol. 1997 Mar;64(3):493-5. doi: 10.1006/gyno.1996.4605.
Reference Type
BACKGROUND
Li M, Macedo A, Crawford S, Bagha S, Leung YW, Zimmermann C, Fitzgerald B, Wyatt M, Stuart-McEwan T, Rodin G. Easier Said Than Done: Keys to Successful Implementation of the Distress Assessment and Response Tool (DART) Program. J Oncol Pract. 2016 May;12(5):e513-26. doi: 10.1200/JOP.2015.010066. Epub 2016 Apr 5.
Reference Type
BACKGROUND
Brard L, Weitzen S, Strubel-Lagan SL, Swamy N, Gordinier ME, Moore RG, Granai CO. The effect of total parenteral nutrition on the survival of terminally ill ovarian cancer patients. Gynecol Oncol. 2006 Oct;103(1):176-80. doi: 10.1016/j.ygyno.2006.02.013. Epub 2006 Mar 27.
Reference Type
BACKGROUND
Madariaga A, Jivraj N, Soberanis Pina P, Somji F, Truong T, Melwani S, Lovas M, Gogos TA, Sajewycz K, Bhat G, Alqaisi H, Gonzalez-Ochoa E, Veneziani A, Garg V, Dhani NC, Grant R, Bowering V, Oza AM, Wang L, Berlin A, Lheureux S. Electronic malignant bowel obstruction symptom monitoring smartphone application for patients with gynecologic cancers. Int J Gynecol Cancer. 2024 Oct 7;34(10):1612-1618. doi: 10.1136/ijgc-2024-005490.
Reference Type
DERIVED
Cusimano MC, Sajewycz K, Nelson M, Jivraj N, Lee YC, Bowering V, Oza A, Lheureux S, Ferguson SE. Supported self-management as a model for end-of-life care in the setting of malignant bowel obstruction: A qualitative study. Gynecol Oncol. 2020 Jun;157(3):745-753. doi: 10.1016/j.ygyno.2020.03.009. Epub 2020 Mar 23.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MAMBO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer
NCT02527382
COMPLETED
NA
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients
NCT06056726
UNKNOWN
Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer
NCT06338332
RECRUITING
Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
NCT02658565
ACTIVE_NOT_RECRUITING
NA
FloSeal in CRS and HIPEC
NCT01957852
COMPLETED
Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
NCT01527396
COMPLETED
Prediction of Occult Peritoneal Metastasis of Locally Advanced Gastric Cancer Using Multimodal Data Based on Artificial Intelligence Combined With Intraoperative Dynamic Video
NCT06478368
COMPLETED
Vessel- and Bone-based Ultrasound Registration
NCT05637346
COMPLETED
NA
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
NCT06146946
RECRUITING
NA
Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients
NCT02575859
COMPLETED
PHASE1/PHASE2
Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis
NCT02493972
COMPLETED
NA
Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy
NCT05134142
RECRUITING
Total/Subtotal Colectomy in Ovarian Cancer
NCT02595021
UNKNOWN
PHASE2
Prediction of Ovarian Cancer Histotypes and Surgical Outcome
NCT07057167
NOT_YET_RECRUITING
Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases
NCT05665322
TERMINATED
NA
Liquid Biopsies and IMAging for Improved Cancer Care
NCT04224779
ACTIVE_NOT_RECRUITING
NA
Second Look Laparoscopy in Colorectal Cancer
NCT01628211
UNKNOWN
PHASE2
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
NCT02179489
COMPLETED
NA
Proactive Management of Endoperitoneal Spread in Colonic Cancer
NCT02974556
UNKNOWN
PHASE3
Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
NCT06524583
RECRUITING
PHASE2
Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer
NCT01512810
COMPLETED
PHASE2
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
NCT04727242
ACTIVE_NOT_RECRUITING
PHASE2
Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases
NCT02758951
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer
NCT01946672
COMPLETED
PHASE4
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
NCT04573621
UNKNOWN
NA