Peptic Ulcer
Conditions
Keywords
ulcer repair surgery, transluminal omental patch
Brief summary
This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to patch or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed Hypothesis: The primary outcome is successful completion of the procedure.
Detailed description
Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts for more than 70% of deaths associated with peptic ulcer disease. In addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. Age, time to presentation and comorbidities are not factors that can be influenced. If it would be possible to reduce the impact of procedure related complications or the second hit, that may lead to decreased morbidity and mortality. This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.
Interventions
DEVICEEndoscopic Translumenal Omental Patch
The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.
Sponsors
Natural Orifice Surgery Consortium for Assessment and Research
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention * Surgical candidate for endoscopic, laparoscopic, or open procedure * Age \> 21 * Informed written consent
Exclusion criteria
* Prior gastric or duodenal surgery * Prior total abdominal colectomy or transverse colectomy * Prior omentectomy or omental flaps * Known perforation site other than stomach or duodenum * Patients with contra-indications for laparoscopy * Patients with contraindications for endoscopy * Upper gastrointestinal anatomy that would preclude endoscopic therapy * Coagulopathy or thrombocytopenia * Pregnant patients * Patients \<21 years of age * Prisoners * Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair | 2 days post-operation | At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled between February 2010 and February 2012 at Mayo Clinic in Rochester, Minnesota.
Participants by arm
| Arm | Count |
|---|---|
| Endoscopic Translumenal Omental Patch Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient deterioration prior to procedure | 3 |
| Overall Study | Surgeon decision | 1 |
Baseline characteristics
| Characteristic | Endoscopic Translumenal Omental Patch |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair
At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated.
Time frame: 2 days post-operation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endoscopic Translumenal Omental Patch | Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair | Participants completing NOTES repair | 2 participants |
| Endoscopic Translumenal Omental Patch | Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair | Participants completing other procedure | 1 participants |