Pelvic Organ ProlapsePhase 1MBPNCT01522261
The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other.
A Phase 1 study testing Mechanical Bowel Prep and No Mechanical Bowel Prep in people with Pelvic Organ Prolapse, run by Boston Urogynecology Associates at 1 site in United States.
Trial summary
Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery? Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Mechanical Bowel Prep and No Mechanical Bowel Prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2017
- Phase
- Phase 1
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:
- Laparoscopic sacrocervicopexy
- Laparoscopic sacrocolpopexy
- Laparoscopic sacrohysteropexy
- Laparoscopic uterosacral ligament suspension
- Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires
Who cannot join
- Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
- History of abdominal malignancy
- History of surgical debulking for previous malignancy
- Non-english speaking
- Pregnancy
- Hx of abdomino-pelvic radiation
- Contraindications to Sodium Phosphate
- Contraindications to laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
Kathleen J Rogers, 617-354-5452, krogers2@mah.harvard.edu
Lekha Hota, M.D., 617-354-5452, lhota@mah.harvard.edu
About this study
Official title: The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)
Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?
Read the detailed description
Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure that the rectum is empty of all stool. This will be done since some surgeons use a rectal probe in the rectum to help with manipulation during the procedure. Stool in the rectal vault could contaminate the surgical field and lead to an infection.
Patients will be randomized at their pre-op visit and provided instructions according to the group assignment. On the day of surgery patients will be asked to complete a questionnaire in the pre-op holding area to assess their overnight symptoms including insomnia, weakness, abdominal distention, nausea, thirst and overall tolerability of the Bowel Preparation assigned.
Immediately after surgery, the primary surgeon will be asked to complete a visual analog score sheet evaluating the ease of the procedure with regard to retraction of the large and small bowel to help with visualization of the sacral promontory, retraction from posterior cul-de-sac, and maintaining adequate positioning after retraction. All surgeons (attendings, fellows, and residents) will be blinded re: the patients group assignment. Each primary surgeon will be asked to assign a final grade to the procedure as easy, medium, or difficult based on overall bowel retraction.
At their 2 week follow up visit patients will be asked to report return of bowel function (first bowel movement or flatus) in # of days after surgery and incidents of stool leakage post op.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Mechanical Bowel Prep, No Mechanical Bowel Prep
- Keywords
- Mechanical Bowel Prep
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Bowel PrepOther
Patients randomized to MBP will complete procedure per standard instructions.
No Mechanical Bowel PrepOther
Patient randomized to fleets enemas only prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Bowel Prep | Active comparator | Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery. Receives: Other: Mechanical Bowel Prep |
| No Mechanical Bowel Prep. | Active comparator | Patients randomized to complete two fleets enemas only prior to surgery. Receives: Other: No Mechanical Bowel Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures.
The primary objective of this protocol is to determine whether there is truly an advantage for the surgeon (visually) in having patients complete a Mechanical Bowel Prep prior to surgery or if an enema completed the evening before and morning of the surgery is sufficient.
Measured: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.
Secondary outcomes (1)
To evaluate whether MBP (total bowel cleansing) delays the return of bowel function and/or increases the risk of perioperative leakage of stool (fecal incontinence)post operatively.
Measured: We will be following the subject from the day of surgery through 2 weeks post op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Urogynecology Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lekha S. Hota, Boston Urogynecology Associates
- Investigators
- Lekha Hota, M.D., Principal investigator, Boston Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522261
- Sponsor's protocol ID
- BUA 007-2011
- Acronym
- MBP
- Status last verified
- Apr 2015
- First submitted
- 9 Jan 2012
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Adelowo AO, Hacker MR, Modest AM, Apostolis CA, Disciullo AJ, Hanaway KJ, Elkadry EE, Rosenblatt PL, Rogers KJ, Hota LS. The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):1-7. doi: 10.1097/SPV.0000000000000346.
PubMed 27782976
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)
- ClinicalTrials.gov ID
- NCT01522261
- Acronym / sponsor ID
- MBP / BUA 007-2011
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Mechanical Bowel Prep
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Boston Urogynecology AssociatesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 31 Jan 2012 (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.
Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?
Detailed description
Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure that the rectum is empty of all stool. This will be done since some surgeons use a rectal probe in the rectum to help with manipulation during the procedure. Stool in the rectal vault could contaminate the surgical field and lead to an infection.
Patients will be randomized at their pre-op visit and provided instructions according to the group assignment. On the day of surgery patients will be asked to complete a questionnaire in the pre-op holding area to assess their overnight symptoms including insomnia, weakness, abdominal distention, nausea, thirst and overall tolerability of the Bowel Preparation assigned.
Immediately after surgery, the primary surgeon will be asked to complete a visual analog score sheet evaluating the ease of the procedure with regard to retraction of the large and small bowel to help with visualization of the sacral promontory, retraction from posterior cul-de-sac, and maintaining adequate positioning after retraction. All surgeons (attendings, fellows, and residents) will be blinded re: the patients group assignment. Each primary surgeon will be asked to assign a final grade to the procedure as easy, medium, or difficult based on overall bowel retraction.
At their 2 week follow up visit patients will be asked to report return of bowel function (first bowel movement or flatus) in # of days after surgery and incidents of stool leakage post op.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel Prep | Active comparator | Other: Mechanical Bowel PrepPatients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery. |
| No Mechanical Bowel Prep. | Active comparator | Other: No Mechanical Bowel PrepPatients randomized to complete two fleets enemas only prior to surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:
- Laparoscopic sacrocervicopexy
- Laparoscopic sacrocolpopexy
- Laparoscopic sacrohysteropexy
- Laparoscopic uterosacral ligament suspension
Key exclusion criteria (8 listed)
- Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
- History of abdominal malignancy
- History of surgical debulking for previous malignancy
- Non-english speaking
- Pregnancy
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 |
|---|---|---|
| Mechanical Bowel PrepPatients randomized to MBP will complete procedure per standard instructions. | Other | Mechanical Bowel Prep |
| No Mechanical Bowel PrepPatient randomized to fleets enemas only prior to surgery | Other | No Mechanical Bowel Prep. |
Primary outcome
To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures.
Time frame: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.
The primary objective of this protocol is to determine whether there is truly an advantage for the surgeon (visually) in having patients complete a Mechanical Bowel Prep prior to surgery or if an enema completed the evening before and morning of the surgery is sufficient.
1 secondary outcome
To evaluate whether MBP (total bowel cleansing) delays the return of bowel function and/or increases the risk of perioperative leakage of stool (fecal incontinence)post operatively.
Time frame: We will be following the subject from the day of surgery through 2 weeks post op.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Derived from this study: PubMed 27782976Adelowo AO, Hacker MR, Modest AM, Apostolis CA, Disciullo AJ, Hanaway KJ, Elkadry EE, Rosenblatt PL, Rogers KJ, Hota LS. The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):1-7. doi: 10.1097/SPV.0000000000000346.
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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.
Lekha Hota, M.D. principal investigator
Boston Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mechanical Bowel Prep and No Mechanical Bowel Prep in people with Pelvic Organ Prolapse, run by Boston Urogynecology Associates at 1 site in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 20 Apr 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 States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. (time frame: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.). 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 NCT01522261, which also lists 1 linked publication.
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 20 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.