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Transrectal NOTES Appendectomy - Feasibility Study

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ClinicalTrials.gov Identifier: NCT01189916
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : February 13, 2015
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Anne-Marie Boller, Northwestern University

Brief Summary:

Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal approaches. The transvaginal approach is technically easier, but is only available to women. A transrectal approach has been proposed as a potential alternative to transvaginal NOTES for men. Fortunately, the technology to facilitate transrectal access and closure for NOTES has been in use for over twenty years, in the form of transanal endoscopic microsurgery (TEM) platforms.

We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible endoscope and a TEM platform to assist with transrectal access and closure. After a pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal NOTES appendectomies in patients already scheduled to undergo laparoscopic total proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure will be removed as part of the patient's originally scheduled operation, reducing the risk of morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We will measure operative times, complication rates, peritoneal contamination, and assess the integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is clinically feasible in humans using a TEM platform.


Condition or disease Intervention/treatment Phase
Appendectomy, Laparoscopic Endoscopy Procedure: Endoscopically assisted Appendectomy Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transrectal - Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Study Start Date : August 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Transrectal NOTES appendectomy
These patients will undergo an experimental surgical procedure that uses flexible endoscopic instruments (i.e., inserted through the rectum).
Procedure: Endoscopically assisted Appendectomy Surgery
Using endoscopic instruments a small incision will be made in the rectum wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The appendix will be removed through the anus. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the rectal access site.
Other Names:
  • NOTES
  • Natural orifice translumenal endoscopic surgery
  • Transrectal Appendectomy




Primary Outcome Measures :
  1. operative time [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. perioperative complications [ Time Frame: two weeks ]
  2. closure strength [ Time Frame: intraoperative ]
    Rectotomy closure strength will be measured intraoperatively using air insufflation, as well as postoperatively using pressurized fluid on the specimen.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ability to undergo general anesthesia
  • Age > 18 yrs
  • ability to give informed consent
  • requires total proctocolectomy,total abdominal colectomy, completion proctectomy, or sigmoidectomy
  • absence of exclusion criteria

Exclusion Criteria:

  • age < 18
  • pregnancy
  • emergency operation
  • contraindication for laparoscopic surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189916


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Natural Orifice Surgery Consortium for Assessment and Research
Investigators
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Principal Investigator: Anne-Marie Boller, M.D. Northwestern University

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Responsible Party: Anne-Marie Boller, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01189916    
Other Study ID Numbers: STU00023311
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015