Transrectal NOTES Appendectomy - Feasibility Study

NCT01189916 | Completed

• 1 other identifier: STU00023311
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendectomy, Laparoscopic; Endoscopy

Outcome Measures

Primary Outcomes (1)

• operative time

  intraoperative

Secondary Outcomes (2)

• perioperative complications

  two weeks

• closure strength

  intraoperative

Study Arms (1)

Transrectal NOTES appendectomy

EXPERIMENTAL

These patients will undergo an experimental surgical procedure that uses flexible endoscopic instruments (i.e., inserted through the rectum).

Procedure: Endoscopically assisted Appendectomy Surgery

Interventions

Endoscopically assisted Appendectomy Surgery PROCEDURE

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.

Also known as: NOTES, Natural orifice translumenal endoscopic surgery, Transrectal Appendectomy

Transrectal NOTES appendectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Natural Orifice Surgery Consortium for Assessment and Research: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

• Anne-Marie Boller, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 13, 2015

Record last verified: 2015-02

Locations

US (1)