Skip to main content
OpenTrials
Completed

NCT Number: NCT03260647

Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Cancer

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

There are no specified exclusion criteria for this study

Treatment and study plan

Management algorithm for Malignant Bowel Obstruction

Other

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

Primary outcomes

  1. Optimization of multidisciplinary care

    Time frame: 2 years

    To optimize the multidisciplinary care management of MBO in patients with advanced gynecological cancer treated at University Health Network (UHN) which include in-patient and ambulatory management algorithm for MBO

    • Measured by a ratio of days alive and out of hospital compare to days in hospital within the first 60 days after diagnosis of MBO

Secondary outcomes

  1. Evaluation of treatment outcomes

    Time frame: 2 years

    To evaluate the treatment outcomes of patients with MBO

    • Measured by resolution of MBO and overall survival
    • Measured by transition through specific bowel management colour code system

  2. Evaluation of impact of MBO management on hospital visits

    Time frame: 2 years

    To evaluate the impact of MBO management on number of emergency room visits, hospital admission and number of days alive and outside of hospital within the first 168 days (6 months) after the diagnosis of MBO

  3. Evaluation of impact of MBO management on patient reported outcomes

    Time frame: 2 years

    To evaluate the impact of ambulatory MBO management on patient reported outcomes using the Distress Assessment & Response Tool (DART)

  4. To evaluate nutritional status of patients with MBO

    Time frame: 2 years

    To evaluate the nutritional status of patients with MBO

    • Measured by monthly albumin and weight

  5. Evaluation of clinico-pathological factors

    Time frame: 2 years

    To evaluate the clinico-pathological factors that may predict benefit from palliative surgery, chemotherapy and total parenteral nutrition (TPN)

  6. Improve patient understanding and awareness of MBO

    Time frame: 2 years

    To improve patients' understanding and awareness of MBO with patient education material.

  7. Determine percentage number of patient microbiome sample analyses completed

    Time frame: 1.5 years

    To record the percentage of patients who agree to, and for whom sample collection and analysis is completed

  8. Record changes in the sum and types of gut microbiome from baseline to study end

    Time frame: 1.5 years

    Changes in the sum as well as types of microbiomes as recorded at baseline, initiation of total parenteral nutrition, incidence of an MBO and end of study are to be recorded

  9. Evaluate cannabis use in patient population

    Time frame: 1.5 years

    Assess for any relationship between cannabis use and MBO

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction (MAMBO) Program for Women With Advanced Gynecological Cancers

Acronym: MAMBO

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 24, 2017
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.