How is your proctology patient really doing? Outcome measurement in proctology: development, design and validation study of the Proctoprom.

BACKGROUND: The aim of the present study was to develop and evaluate the reliability and validity of proctology patient-reported outcome measurements (PROM): Proctoprom. METHODS: Development of the Proctoprom was based on interview rounds with experts (n = 4) and patients (n = 19) in open informal interview rounds regarding content and form. Once consensus was achieved on five items, data were collected between July 2014 and August 2016 from 991 patients recruited consecutively in a specialized proctology center. Reliability, construct validity and responsiveness of the PROM were determined through exploratory factor analysis, test-retest analysis and anchor-based hypothesis testing. We also estimated discriminant validity, standard error of measurement (SEM), minimal detectable change (MDC95%) and minimal clinically important difference (MCID). RESULTS: The five items loaded on one factor that reflected good internal consistency (Cronbach's α 0.81). Test-retest analysis showed good reliability with intraclass correlation of 0.81. Construct validity measurement resulted in AUCs of 0.85 and 0.90. Responsiveness measurement resulted in AUCs of > 0.76 for both hypotheses. SEM was estimated at 3.0 points and MDC at 4.8 points. We estimated an MCID of 10 points. CONCLUSIONS: Proctoprom is a valid and reliable tool that is responsive to change and that meets consensus-based standards for the selection of health measurement instruments. It can be used to evaluate disease burden and effect of treatment in all adult proctology patients regardless of their proctologic diagnosis.

Perianal fistulas and the lift procedure: results, predictive factors for success, and long-term results with subsequent treatment.

BACKGROUND: Treatment of a perianal fistula is difficult due to the risk of fecal incontinence and recurrence. The ligation of intersphincteric tract (LIFT) procedure is a sphincter-saving procedure associated with success rates ranging from 57 to 94%. The aim of our study was to find predictors for a favorable outcome of the LIFT procedure, evaluation of postoperative fecal incontinence, quality of life, and subsequent treatment with long-term follow-up. METHODS: This study was performed in patients who underwent LIFT between 2013 and 2015 at our institution. Their medical data were retrieved from the electronic patient files. The fistula characteristics were described by physical examination, three-dimensional endoanal ultrasound, and perioperative evaluation. Recurrence rate, postoperative fecal incontinence, and quality of life were assessed with the Patient-Reported Outcome Measurement (PROM). Thirty-two months later, long-term follow-up including subsequent procedures was evaluated. RESULTS: Forty-five patients [17 men, mean age 40 years (range 24-67 years)] were included. In 41 (84%) patients, the fistula was classified as complex; 32 (71%) were referrals with a history of previous fistula surgery. The initial success rate was 18 (40%). Only the height of the internal fistula opening (≥ 15 mm p < 0.03) was associated with recurrence. The LIFT procedure did not affect the occurrence of fecal incontinence or soiling. Recurrence showed a trend with a lower PROM (p = 0.07). Twenty-four months later, further surgery leads to cure in 34 (75%), asymptomatic fistulas in 7 (16%), and persisting active fistulas in 4 (9%) patients. CONCLUSIONS: Initial LIFT had a success rate of 40% and with subsequent surgical treatment 75%. Recurrence after LIFT is related to the height of the internal fistula opening and is associated with diminished quality of life. Continence was not affected by initial LIFT.

Randomized clinical trial of mesh fixation with "double crown" versus "sutures and tackers" in laparoscopic ventral hernia repair.

BACKGROUND: Although laparoscopic intra-peritoneal mesh repair (LVHR) is a well-established treatment option to repair ventral and incisional hernias, no consensus in the literature can be found on the best method of fixation of the mesh to the abdominal wall. METHODS: Between December 2004 and July 2008, 76 patients undergoing a LVHR were randomized between mesh fixation using a double row of spiral tackers (DC) (n = 33) and mesh fixation with transfascial sutures combined with one row of spiral tackers (S&T) (n = 43), in the WoW trial (with or without sutures). Patients were clinically examined and evaluated using a visual analog scale for pain (VAS) in rest and after coughing 4 h post-operatively, after 4 weeks and 3 months after surgery. Primary endpoint of the study was abdominal wall pain, defined as a VAS score of at least 1.0 cm, at 3 months post-operative. Quality of life was quantified with the SF-36 questionnaire preoperatively and after 3 months. Secondary endpoint was the recurrence rate at 24-month follow-up. RESULTS: The DC and S&T group were comparable in age, gender, ASA score, BMI, indication, hernia, and mesh variables. The DC group had a significant shorter operating time compared with the S&T group (74 vs 96 min; p = 0.014) and a significant lower mean VAS score 4 h post-operatively (in rest; p = 0.028/coughing; p = 0.013). At 3 months, there were significant more patients in the S&T group with VAS score ≥1.0 cm (31.4 vs 8.3 %; p = 0.036). Clinical follow-up at 24 months was obtained in 63 patients (82.9 %). The recurrence rate at 24 months was 7.9 % overall (5/63). There were more recurrences in the S&T group (4/36) than in the DC group (1/27), but this difference was not significant (11.1 vs 3.7 %; p = 0.381). CONCLUSION: We found that double-crown fixation of intra-peritoneal mesh during laparoscopic ventral hernia repair was quicker, was less painful immediately post-operative and after 3 months, and did not increase the recurrence rate at 24 months. In hernias at a distance from the bony borders of the abdomen, transfascial sutures can be omitted if a double crown of tackers is placed.

Laparoscopic intraperitoneal repair of incisional and ventral hernias.

BACKGROUND: After reports in the literature on the safety and feasibility of laparoscopic repair of ventral hernia, and with the potential advantages of the minimal invasive approach, we started to perform this technique in 2001. This study was done to evaluate the results of our initial experience. METHODS: From March 2001 to October 2003, all patients with a ventral hernia greater than 4 cm were planned to have a laparoscopic repair. Patients were studied retrospectively, collecting data on preoperative and intraoperative variables, complications and recurrences. RESULTS: In 49 patients, out of 52 patients planned, laparoscopic repair was performed. The indication was incisional hernia in 88% and recurrence after open hernia repair in 43%. The mean hernia surface area was 86,6 cm2 and 43% had a width greater than 10 cm. There were no intraoperative complications and the mean operating time was 103 min. Postoperative complications were seen in 9 patients (18,4%). Mean hospital stay was 5,9 days. Mean follow-up was 14,3 months. Late complications were seen in three patients (6,1%). Recurrence was present in one patient (2,0%). CONCLUSIONS: Laparoscopic repair of incisional and ventral hernia is a safe alternative for open mesh repair. Further definition of indications is needed, based on the dimension and the localization of the hernia. If the omission of transabdominal wall sutures improves the postoperative course with no adverse effect on recurrence rate, will be the subject of a randomized trial we have started this year.