Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial

Abstract

Background Ulcer perforation carries up to a 30% 1-year mortality rate. Intervention-related adverse events are among statistically significant predictors of 1-year mortality. A Natural Orifice Transluminal Endoscopic Surgical (NOTES) approach may be less invasive and may decrease procedure-related adverse events by diminishing the "second hit", thus leading to decreased morbidity and mortality. Aim To assess the feasibility of an endoscopic transluminal omental plug technique in patients with perforated gastroduodenal ulcers under laparoscopic guidance. Methods Patients with suspected acute gastroduodenal ulcer perforations were offered participation in this prospective pilot study. Closure of the perforation was attempted using NOTES omental plug technique. Demographic, clinical, endoscopic and radiographic data were abstracted, as well as morbidity, mortality and pilot data regarding quality of life (QOL). Results From February 2010 through Feb 2012, 17 patients presented to a tertiary care center with clinically suspected perforated ulcer. Of seven patients (mean age 79, range 64–89) who consented to the study, three underwent the study procedure. All patients had multiple comorbidities. Two patients presented with 4–6 mm perforated peptic ulcers and underwent successful laparoscopic-assisted NOTES omental and falciform ligament patch closure, respectively. Postoperative radiographic contrast studies showed no leak and patients were discharged home on postoperative days 3 and 4. The third patient had undergone enterocutaneous fistula repair with herniorrhaphy 6 weeks prior; a transluminal endoscopic approach was feasible; however, the omentum was under too much tension to be secured. This procedure was converted to an open omental patch repair. For all but one consented patient, obtaining QOL data was feasible. Conclusion Initial results from a laparoscopic-assisted NOTES approach for closure of perforated peptic ulcers appear promising and enable swift recovery in selected patients. This is especially important in the elderly and/or immunocompromised patients. Technical details and patient selection criteria continue to evolve.

Strategies to improve the outcome of emergency surgery for perforated peptic ulcer

“…The trial is recorded as completed in January 2013, with enrolment of 61 patients (all adults, perforations smaller than 5 mm, American Society of Anesthesiologists (ASA) grade I–II, no shock on admission), but no published results were found. One further registered trial (NCT01080326) investigated the feasibility of endoscopic omental patch repair in three patients, of whom two underwent natural orifice transluminal endoscopic surgery.…”

“…In addition, the optimal laparoscopic surgical technique for closure of the perforation remains unknown; the decision rests on whether or not to use an omental patch. Finally, the latest options for PPU include endoscopic closure and natural orifice transluminal treatment, which has been reported in a few small series; these remain experimental and beyond the scope of this review.…”

Natural orifice transluminal endoscopic surgery for intra-abdominal emergency conditions

“…With the advent of a new technique, the operating time is frequently longer than that for the standard approach. The time taken for successful repair of ulcer perforations by a NOTES approach is similar to historical data for open or laparoscopic omental patch closure. Procedure duration is easiest to compare for NOTES appendicectomy as a number of studies have reported duration of operation for traditional laparoscopy, single‐port laparoscopy, and the transvaginal and transgastric approach to NOTES appendicectomy.…”

“…In a retrospective review of 100 operative reports, the procedure was deemed possible in about 50 per cent. The technique was developed and studied extensively in an animal model, and a pilot trial was performed in humans to demonstrate feasibility. Haemodynamically stable patients with a suspected perforated ulcer were potentially eligible for a NOTES procedure.…”

A light-reflecting balloon catheter for atraumatic tissue defect repair

“…The hole can be medically managed or treated surgically or laparoscopically (14)(15)(16). Initial results from a natural orifice transluminal endoscopic surgery (NOTES) device are promising for quick recovery times, but these approaches leave permanent clips in the body (17). A similar approach to NOTES that does not leave permanent materials behind, but rather a scaffold that facilitates native tissue healing, could be advantageous for clinical translation.…”