A feasibility and dosimetric evaluation of endoscopic radiofrequency ablation for human colonic and rectal epithelium in a treat and resect trial.

BACKGROUND: Endoscopic radiofrequency ablation (RFA) has been used effectively for ablation of foregut disorders and also may have a role in treating colonic pathology. This study aimed to assess the feasibility of delivering RFA to locations within the colon and to determine a range of safe treatment parameters. METHODS: Patients undergoing left hemicolectomy or proctocolectomy were evaluated. Focal RFA using a colonoscope-mounted device was delivered to normal segments of the colon and rectum within the planned surgical resection specimen. Endoscopic accessibility and feasibility of delivering heat energy to the colon and rectum were assessed as well as the maximum incurred histologic depth of ablation in relation to the number of applications (2 or 4) and the energy density (12, 15, or 20 J/cm2). RESULTS: A total of 51 ablation zones in 16 patients had available histopathology. None of the sites receiving two applications demonstrated serosal layer alteration compared with 15% of the sites receiving four applications (p=0.11). Muscularis propria alterations were seen in 25% of the two-application sites and 63% of the four-application sites (p<0.05). Increasing energy density from 12 to 20 J/cm2 did not correlate with a deeper ablation effect. CONCLUSIONS: Endoscopic RFA is capable of delivering therapy to the distal colon. Injury is limited to the muscularis propria or less depth when no more than two ablations are applied regardless of the energy density used. Based on these feasibility and dosimetry results, the authors will continue investigation using these and smaller energy doses to initiate trials ultimately with patients who have suitable mucosal and submucosal disorders of the lower gastrointestinal tract including chronic, nonulcerated hemorrhagic radiation proctitis and angiodyplasia.

Feasibility of radiofrequency ablation for the treatment of chronic radiation proctitis.

BACKGROUND: Chronic radiation proctitis can be difficult to manage. Radiofrequency ablation has recently been shown to be effective in the management of gastric antral vascular ectasia and Barrett's esophagus, but its utility in the treatment of chronic radiation proctitis is undetermined. METHOD: A 77-year-old man with extensive chronic radiation proctitis had continued bleeding despite argon plasma coagulation. The HALO(90) radiofrequency system (BARRX Medical, Sunnyvale, CA) was used for treatment regions of proctitis at an energy density of 12 J/cm(2). RESULTS: At monthly intervals, over 3 months, radiofrequency ablation was performed with a mean of 7 regions ablated at a time. The mean treatment time was 29 minutes. There was no significant bleeding after the first treatment session. The patient was symptom free at 6 months follow-up with minimal evidence of residual mucosal abnormalities. CONCLUSIONS: Radiofrequency ablation appears feasible for treatment of refractory chronic radiation proctitis, with further studies required.

Prospective randomized double-blind placebo-controlled trial of postoperative elastomeric pain pump devices used after laparoscopic ventral hernia repair.

BACKGROUND: The laparoscopic repair of ventral hernias can result in significant postoperative pain necessitating a prolonged hospital stay, increased narcotic use, and patient dissatisfaction. Elastomeric pain pump devices with local analgesics may significantly reduce postoperative discomfort after laparoscopic ventral hernia repair. This prospective randomized, double-blind, placebo-controlled study evaluated the effect of local anesthetic continuously infused with an elastomeric pain pump device to reduce postoperative pain. METHODS: After institutional review board approval of the study, all patients undergoing laparoscopic ventral hernia repair consented to participate. Standardized technique included routine transfascial fixation sutures and titanium spiral tacks. Elastomeric pain pumps were placed percutaneously just above the mesh in the hernia sac. For 48 h postoperatively, 100 ml of continuous 0.5% Marcaine or normal saline was used at 2 ml/h. Postoperatively, the patients were evaluated every 8 h for the first 72 h, then after 2 weeks, 6 weeks, and 3 months for pain scores, narcotic usage (both oral and intravenous), return of flatus, length of hospital stay, and postoperative complications. RESULTS: Of the 73 patients enrolled in the study, 37 received 0.5% Marcaine, and 36 received placebo. Despite randomization, the control group had significantly more obese patients (mean body mass index [BMI], 39 vs. 33 kg/m(2); p = 0.005), and more recurrent hernias (40% vs. 19%; p = 0.05), and also tended to have more prior hernia repairs (0.8 vs. 0.3; p = 0.06). There were no significant differences between the two groups in terms of operative times (p = 0.7), hernia size (p = 0.9), mesh size (p = 0.6), number of transfascial fixation sutures (p = 0.4), or number of spiral tacks (p = 0.13). Postoperative visual analog pain scores, usage of oral or intravenous narcotics, and morphine equivalents were similar between the two groups at all study points (p > 0.05). There were no significant differences between the two groups based on return of bowel function, toleration of a regular diet, or length of hospital stay. No postoperative complications directly related to the catheter were observed. CONCLUSIONS: This prospective randomized double-blind, placebo-controlled trial showed no advantage of an elastomeric pain pump device in terms of providing a measurable reduction in postoperative pain scores, narcotic use, time to return of bowel function, or length of hospital stay after laparoscopic ventral hernia repair. Further studies are warranted to determine other alternatives for reducing postoperative pain after laparoscopic ventral hernia repair.

Validation of a novel postoperative quality-of-life scoring system.

BACKGROUND: No specific scoring system exists for the assessment of postoperative quality of life (QOL) after major abdominal surgery. This study prospectively validates PQL, a novel prospective scoring system in patients having laparoscopic or open major abdominal colorectal surgery. METHODS: Six experienced surgeons developed the questionnaire. Twenty patients reviewed and selected the most relevant questions, yielding 14 questions. One hundred patients undergoing a variety of colorectal procedures completed the questionnaire preoperatively, and on postoperative days (POD) 1, 2, 4, 8, 12, 30, and 60. Internal validation was assessed by Cronbach's alpha and factor analysis. RESULTS: Cronbach's alpha revealed excellent internal consistency, ranging from .84 to .94 at all time points, even at POD 1 when Cronbach's alpha was .79, demonstrating that the items in the questionnaire measured the same underlying construct. Factor analysis consistently loaded at each follow-up time on the same 2 factors. CONCLUSIONS: Factor analysis consistently loaded at each follow-up time on the same 2 factors, designated the PQL Symptom Score and the PQL Recover Score.