Malaika S. Vlug

Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study).

Objective:To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer. Summary Background Data:Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care, both focusing on faster recovery. Methods:In a 9-center trial, patients eligible for segmental colectomy were randomized to laparoscopic or open colectomy, and to FT or standard care, resulting in 4 treatment groups. Primary outcome was total postoperative hospital stay (THS). Secondary outcomes were postoperative hospital stay (PHS), morbidity, reoperation rate, readmission rate, in-hospital mortality, quality of life at 2 and 4 weeks, patient satisfaction and in-hospital costs. Four hundred patients were required to find a minimum difference of 1 day in hospital stay. Results:Median THS in the laparoscopic/FT group was 5 (interquar-tile range: 4–8) days; open/FT 7 (5–11) days; laparoscopic/standard 6 (4.5–9.5) days, and open/standard 7 (6–13) days (P < 0.001). Median PHS in the laparoscopic/FT group was 5 (4–7) days; open/FT 6 (4.5–10) days; laparoscopic/standard 6 (4–8.5) days and open/standard 7 (6–10.5) days (P < 0.001). Secondary outcomes did not differ significantly among the groups. Regression analysis showed that laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity. Conclusions:Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program. If open surgery is applied, it is preferentially done in FT care. This study was registered under NTR222 (www.trialregister.nl).

Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery.

BACKGROUND & AIMS Postoperative ileus is characterized by delayed gastrointestinal (GI) transit and is a major determinant of recovery after colorectal surgery. Both laparoscopic surgery and fast-track multimodal perioperative care have been reported to improve clinical recovery. However, objective measures supporting faster GI recovery are lacking. Therefore, GI transit was measured following open and laparoscopic colorectal surgery with or without fast-track care. METHODS Patients (n = 93) requiring elective colonic surgery were randomized to laparoscopic or conventional surgery with fast-track multimodal management or standard care, resulting in 4 treatment arms. Gastric emptying and colonic transit were scintigraphically assessed from days 1 to 3 in 78 patients and compared with clinical parameters such as time to tolerance of solid food and/or bowel movement and time until (ready for) discharge. RESULTS A total of 71 patients without mechanical bowel obstructions or surgical complications requiring intervention were available for analysis. No differences in gastric emptying 24 hours after surgery between the different groups were observed (P = .61). However, the median colonic transit of patients undergoing laparoscopic/fast-track care was significantly faster compared with the laparoscopic/standard, open/fast-track, and open/standard care groups. Multiple linear regression analysis showed that both laparoscopic surgery and fast-track care were significant independent predictive factors of improved colonic transit. Both were associated with significantly faster clinical recovery and shorter time until tolerance of solid food and first bowel movement. CONCLUSIONS Colonic transit recovers significantly faster after laparoscopic surgery and the fast-track program; laparoscopy and fast-track care lead to faster recovery of GI motility and improve clinical recovery.

Identification of clinical outcome measures for recovery of gastrointestinal motility in postoperative ileus.

Objective:To identify clinical hallmarks associated with recovery of gastrointestinal transit. Background:Impaired gastrointestinal transit or postoperative ileus largely determines clinical recovery after abdominal surgery. However, validated clinical hallmarks of gastrointestinal recovery to evaluate new treatments and readiness for discharge from the hospital are lacking. Methods:Gastric emptying and colonic transit were scintigraphically assessed from postoperative day 1 to 3 in 84 patients requiring elective colonic surgery and were compared with clinical parameters. The clinical hallmark that best reflected recovery of gastrointestinal transit was validated using data from a multicenter trial of 320 segmental colectomy patients. Results:Seven of 84 patients developed a major complication with paralytic ileus characterized by total inhibition of gastrointestinal motility and were excluded from further analysis. In the remaining patients, recovery of colonic transit (defined as geometric center of radioactivity ≥2 on day 3), but not gastric emptying, was significantly correlated with clinical recovery (&rgr; = −0.59, P < 0.001). Conversely, the combined outcome measure of tolerance of solid food and having had defecation (SF + D) (area under the curve = 0.9, SE = 0.04, 95% CI = 0.79–0.95, P < 0.001), but not time to first flatus, best indicated recovery of gastrointestinal transit with a positive predictive value of 93% (95% CI = 78–99). Also in the main clinical trial, multiple regression analysis revealed that SF + D best predicted the duration of hospital stay. Conclusions:Our data indicate that the time to SF + D best reflects recovery of gastrointestinal transit and therefore should be considered as primary outcome measure in future clinical trials on postoperative ileus.(Netherlands National Trial Register, number NTR1884 and NTR222)

Small bowel obstruction, incisional hernia and survival after laparoscopic and open colonic resection (LAFA study).

Short‐term advantages to laparoscopic surgery are well described. This study compared medium‐ to long‐term outcomes of a randomized clinical trial comparing laparoscopic and open colonic resection for cancer.

The prevalence of dysplasia in the ileoanal pouch following restorative proctocolectomy for ulcerative colitis with associated dysplasia.

Aim  A recent systematic review indicated that dysplasia present before restorative proctocolectomy is a predictor of subsequent dysplasia in the pouch. This prospective study was carried out to assess the prevalence of dysplasia in the ileal pouch in patients having RPC for ulcerative colitis with co‐existing dysplasia in the operation specimen.

Genital and Subjective Sexual Response in Women After Restorative Proctocolectomy with Ileal Pouch Anal Anastomosis—A Prospective Clinical Trial

INTRODUCTION Sexual dysfunction after ileo pouch anal anastomosis (IPAA) is common. The most systematic physical reaction to sexual stimulation is an increase in vaginal vasocongestion. Genital response can be assessed by vaginal pulse amplitude (VPA) using vaginal photoplethysmography. AIM To assess whether restorative proctocolectomy with IPAA is associated with autonomic pelvic nerve damage and changes in subjective indices of sexual function in women. METHODS Female patients undergoing IPAA between April 2004 and January 2006 were included. During sexual stimulation (visual and vibrotactile) changes in vaginal vasocongestion were measured by vaginal photoplethysmography. Concurrently, quality of life (SF-36) and sexual functioning (FSFI, FSDS) were assessed using validated questionnaires. MAIN OUTCOME MEASURES Primary endpoint was difference in VPA pre- and postoperatively. Secondary endpoints were differences in feelings of sexual arousal and estimated lubrication pre- and postoperatively and difference in psychological and sexual functioning pre-and postoperatively. RESULTS Eleven patients were included. For eight patients (median age 37 [22-49 years]) pre- and postoperative data were collected. VPA analysis showed a significant reduction in vaginal vasocongestion during sexual stimulation postoperatively, P = 0.012. Subjective sexual arousal and estimated lubrication during the experiment, reported psychological and sexual functioning pre- and postoperative were not different. CONCLUSIONS Vaginal vasocongestion after IPAA was significantly reduced in this small study; indicating that IPAA in women might possibly be associated with autonomic pelvic nerve damage or partial devascularization of the vagina. Subjectively reported sexual arousal, estimated lubrication, psychological and sexual functioning were not diminished. Future research should focus on the possible advantage of a full close rectal dissection in these patients.

Intestinal barrier function in patients undergoing colectomy.

Aim  The aim of this pilot study was to determine whether the type of approach (open or laparoscopic) and the order of devascularization during laparoscopic colectomy affect intestinal barrier function, local inflammatory response and clinical outcome.

Reply to Letter: "Laparoscopy Within Fast-Track or Within Enhanced Recovery After Surgery?"

Reply: W e appreciate the interest of Dr Slim for our paper.1 The author suggests that there is a difference between the “fast track” and the “enhanced recovery” concepts; we, however, see this as merely a question of semantics. In many papers, including a recent paper by Kehlet and Slim, these terms are used interchangeably.2,3 Moreover, the author states that length of stay should no longer be considered as a main endpoint. This is an interesting discussion indeed, but we still consider the length of stay to be an adequate reflection of clinical recovery. This is supported by the work of van Bree et al and by the work of Veenhof et al in a subset of patients enrolled in the LAFA study. Van Bree et al demonstrated that laparoscopic surgery and fast-track care were both significant independent predictors of a faster recovery of colonic transit. Laparoscopy and fast-track care were both associated with improved clinical recovery, shorter time to tolerance of first food, and first bowel movement.4 Veenhof et al showed that the immune function of human leukocyte antigen–DR stayed highest in the group randomized to laparoscopic resection and fast-track care. Also, interleukin-6 and C-reactive protein levels were highest in the patients who had open surgery with standard care.5 Both authors subsequently demonstrated that their findings could be attributed to the type of surgery, not to the type of af-

Reply to letter: "laparoscopy in combination with fast-track management is probably the best perioperative strategy in patients undergoing colonic resection for cancer".

T hank you for the opportunity to respond to the letter of Faucheron, in which he states about 4 more limitations in our study “Laparoscopy in Combination With Fast Track Multimodal Management Is the Best Perioperative Strategy in Patients Undergoing Colonic Surgery: A Randomized Clinical Trial (LAFA-Study).”1 His first and main criticism consists of 2 items. First, he implies that it is more or less impossible to perform a proper randomized trial in the same institution. Second, he notes that patients randomized to fast-track care were immediately aware they had been admitted to a highly specialized and modern ward and were inclined to leave the ward 1 day earlier. Faucheron states that this simple fact explains the significant difference in our primary outcome of total postoperative hospital stay and is therefore a limitation of our study. Regarding the first point, we have certainly been able to study these 2 treatment groups within the same institution by having 2 completely separate wards. Patients were admitted either to a fast-track ward or to a standard care ward. On the fast-track ward, patients were treated only by dedicated nurses, anesthesiologists, physiotherapists, and dieticians who were extensively trained in the principles of fast-track care, and on the standard care ward, the patients were treated only by personnel with no experience at all in fasttrack care. Regarding the second point, we indeed agree that patients were fully aware of being admitted to a fast-track ward, although we do not think that this is a limitation. Patients participating in the LAFA-study were,

In-Hospital Costs of Laparoscopy and/or Fast Track Multimodal Management Versus Open and/or Standard Care in Colonic Surgery (LAFA-Trial)

Introduction: Antimicrobial peptides represent an important component of the innate defense of organisms ranging from plants to insects to humans. They are broad-spectrum, surface acting agents secreted by the epithelial cells of the body including intestine and respiratory tract, which kill microbes. Most such peptides possess activities against bacteria, viruses and fungi. Recently, L-isoleucine and its analogues have been found to induce antimicrobial peptides.Therefore, L-isoleucine might have therapeutic potentials in the management of infectious diarrhea. Vitamin D is another organic molecule in addition to its effect on calcium metabolism, induces antimicrobial peptides secretion through activating the toll like receptor of macrophages and leading to induction of antimicrobial peptides, and killing of bacteria. Bacterial resistance to antibiotics is a growing concern in both nosocomial and community acquired infections. Development and recommendation of newer antimicrobials are much slower than the emergence of bacterial resistance. The use of L-isoleucine and vitamin D might have beneficial effect in the treatment of acute diarrhea in children. Objectives: The objectives of this study were to examine if addition of L-isoleucine and/or vitamin D to a liquid diet reduces the stool weight and/or duration of acute diarrhea in children. Methods: This was a double blind randomized controlled clinical trial in 107 children aged 6 to 36 months attending the ICDDRB hospital with acute diarrhea: 28 children received a) Lisoleucine (2 g/d) added to milk suji(mixture of milk and rice powder, 70 Kcal/100 ml) ; b) 27 received Vitamin D 1000 IU/d added to Milk suji; c) 26 children received L-isoleucine (2g/d) plus vitamin D 1000 IU/d added to milk Suji; d) Milk suji without L-isoleucine and vitamin D. Other managements were similar in all treatment groups. The children remained in the study until recovery from diarrhea but up to a maximum of 5 days. Stool weight and time to resolution of diarrhea were the primary outcomes. Results: Baseline clinical characteristics of the children are comparable between the groups. There is a trend in stool weight (g) reduction in the groups receiving L-isoleucine and the reduction is significant on day 2 (mean ±SD; Control, 447 ± 325 vs. L-isoleucine gr, 276 ± 228 vs. L-isoleucine + Vit. D gr, 301 ± 181 vs. Vit. D gr, 386 ± 302, p=0.039) and day3 (mean ± SD, Control, 341 ± 292 vs. L-isoleucine gr, 176 ± 157 vs. L-isoleucine + Vit. D gr, 267 ± 169 vs. Vit. D gr, 321 ± 273, p=0.045). However, the duration of recovery from diarrhea was similar in four treatment groups. Conclusion: L-isoleucine supplemented food reduces stool weight in children with acute diarrhea. Further large study is recommended to establish the beneficial effect of L-isoleucine supplemented food.