Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula.

BACKGROUND: The role of a collagen plug for treating anal fistula is not well established. A randomized prospective multicentre non-inferiority study of surgical treatment of trans-sphincteric cryptogenic fistulas was undertaken, comparing the anal fistula plug with the mucosal advancement flap with regard to fistula recurrence rate and functional outcome. METHODS: Patients with an anal fistula were evaluated for eligibility in three centres, and randomized to either mucosal advancement flap surgery or collagen plug, with clinical follow-up at 3 and 12 months. The primary outcome was the fistula recurrence rate. Anal pain (visual analogue scale), anal incontinence (St Mark's score) and quality of life (Short Form 36 questionnaire) were also reported. RESULTS: Ninety-four patients were included; 48 were allocated to the plug procedure and 46 to advancement flap surgery. The median follow-up was 12 (range 9-24) months. The recurrence rate at 12 months was 66 per cent (27 of 41 patients) in the plug group and 38 per cent (15 of 40) in the flap group (P = 0·006). Anal pain was reduced after operation in both groups. Anal incontinence did not change in the follow-up period. Patients reported an increased quality of life after 3 months. There were no differences between the groups with regard to pain, incontinence or quality of life. CONCLUSION: There was a considerably higher recurrence rate after the anal fistula plug procedure than following advancement flap repair. Registration number: NCT01021774 (http://www.clinicaltrials.gov).

Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities?

AIM: The aim of the study was to compare patients with symptomatic anastomotic leakage following low anterior resection of the rectum (LAR) for cancer diagnosed during the initial hospital stay with those in whom leakage was diagnosed after hospital discharge. METHOD: Forty-five patients undergoing LAR (n = 234) entered into a randomized multicentre trial (NCT 00636948), who developed symptomatic anastomotic leakage, were identified. A comparison was made between patients diagnosed during the initial hospital stay on median postoperative day 8 (early leakage, EL; n = 27) and patients diagnosed after hospital discharge at median postoperative day 22 (late leakage, LL; n = 18). Patient characteristics, operative details, postoperative course and anatomical localization of the leakage were analysed. RESULTS: Leakage from the circular stapler line of an end-to-end anastomosis was more common in EL, while leakage from the stapler line of the efferent limb of the J-pouch or side-to-end anastomosis tended to be more frequent in LL (P = 0.057). Intra-operative blood loss (P = 0.006) and operation time (P = 0.071) were increased in EL compared with LL. On postoperative day 5, EL performed worse than LL with regard to temperature (P = 0.021), oral intake (P = 0.006) and recovery of bowel activity (P = 0.054). Anastomotic leakage was diagnosed most often by a rectal contrast study in EL and by CT scan in LL. The median initial hospital stay was 28 days for EL and 10 days for LL (P < 0.001). CONCLUSION: The present study has demonstrated that symptomatic anastomotic leakage can present before and after hospital discharge and raises the question of whether early and late leakage after LAR may be different entities.

Reduction in mortality after epidural anaesthesia and analgesia in patients undergoing rectal but not colonic cancer surgery: a retrospective analysis of data from 655 patients in central Sweden.

BACKGROUND: There is some evidence that epidural analgesia (EDA) reduces tumour recurrence after breast and prostatic cancer surgery. We assessed whether EDA reduces long-term mortality after colorectal cancer surgery. METHODS: All patients having colorectal cancer surgery between January 2004 and January 2008 at Linköping and Örebro were included. Exclusion criteria were: emergency operations, laparoscopic-assisted colorectal resection, and stage 4 cancer. Statistical information was obtained from the Swedish National Register for Deaths. Patients were analysed in two groups: EDA group or patient-controlled analgesia (PCA group) as the primary method of analgesia. RESULTS: A total of 655 patients could be included. All-cause mortality for colorectal cancer (stages 1-3) was 22.7% (colon: 20%, rectal: 26%) after 1-5 yr of surgery. Multivariate regression analysis identified the following statistically significant factors for death after colon cancer (P<0.05): age (>72 yr) and cancer stage 3 (compared with stage 1). A similar model for rectal cancer found that age (>72 yr) and the use of PCA rather than EDA and cancer stages 2 and 3 (compared with stage 1) were associated with a higher risk for death. No significant risk of death was found for colon cancer when comparing EDA with PCA (P=0.23), but a significantly increased risk of death was seen after rectal cancer when PCA was used compared with EDA (P=0.049) [hazards ratio: 0.52 (0.27-1.00)]. CONCLUSIONS: We found a reduction in all-cause mortality after rectal but not colon cancer in patients having EDA compared with PCA technique.

Stapled versus robot-sewn ileo-ileal anastomosis during robot-assisted radical cystectomy: a review of outcomes in urinary bladder cancer patients.

BACKGROUND: Whereas the literature has demonstrated an acceptable safety profile of stapled anastomoses when compared to the hand-sewn alternative in open surgery, the choice of intestinal anastomosis using sutures or staples remains inadequately investigated in robotic surgery. The purpose of this study was to compare the surgical outcomes of both anastomotic techniques in robotic-assisted radical cystectomy. METHODS: A retrospective analysis of patients with urinary bladder cancer undergoing cystectomy with urinary diversion and with ileo-ileal intestinal anastomosis at a single tertiary centre (2012-2018) was undertaken. The robotic operating time, hospital stay and GI complications were compared between the robotic-sewn (RS) and stapled anastomosis (SA) groups. The only difference between the groups was the anastomosis technique; the other technical steps during the operation were the same. Primary outcomes were GI complications; the secondary outcome was robotic operation time. RESULTS: There were 155 patients, of which 112 (73%) were male. The median age was 71 years old. A surgical stapling device was used to create 66 (43%) separate anastomoses, while a robot-sewn method was employed in 89 (57%) anastomoses. There were no statistically significant differences in primary and secondary outcomes between RS and SA. CONCLUSIONS: Compared to stapled anastomosis, a robot-sewn ileo-ileal anastomosis may serve as an alternative and cost-saving approach.

Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer.

OBJECTIVE: The aim of this study was to investigate patients with symptomatic anastomotic leakage diagnosed after hospital discharge. METHOD: Patients (n = 234) undergoing low anterior resection of the rectum for cancer who were included in a prospective multicentre trial (NCT 00636948) and who developed symptomatic anastomotic leakage diagnosed after hospital discharge (late leakage, LL; n = 18) were identified. Patient characteristics, operative details, recovery on postoperative day 5, length of hospital stay, and how the leakage was diagnosed were recorded. A comparison with those who did not develop symptomatic leakage (no leakage, NL; n = 189) was made. The minimum follow up was 24 months. RESULTS: In the LL patients the median age was 69 years, 61% were female patients, and 6% had stage IV cancer disease. On postoperative day 5, the LL group had a postoperative course similar to the NL group regarding temperature, oral intake and bowel function. The proportion of patients on antibiotic treatment on postoperative day 5, regardless of indication, was 28% in the LL compared with 4% in the NL group (P < 0.001). The median initial hospital stay was 10 days for both groups. When readmission for any reason was added, the hospital stay rose to a median of 21.5 and 13 days in the LL and the NL groups respectively (P < 0.001). CONCLUSION: Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection of the rectum for cancer is not uncommon and has an immediate clinical postoperative course which may appear uneventful.

Sympathetic (electrodermal) activity during repeated maximal rectal distensions in patients with irritable bowel syndrome and constipation.

Irritable bowel syndrome (IBS) is associated with visceral hypersensitivity, stress and autonomic dysfunction. Sympathetic activity during repeated events indicates excitatory or inhibitory mechanisms such as sensitization or habituation. We investigated skin conductance (SC) during repetitive rectal distensions at maximal tolerable pressure in patients with IBS and chronic constipation. Twenty-seven IBS patients, 13 constipation patients and 18 controls underwent two sets of isobaric rectal distensions. First, maximal tolerable distension was determined and then it was repeated five times. Skin conductance was measured continuously. Subjective symptom assessment remained steady in all groups. The baseline values of SC were higher in IBS patients than in patients with constipation and significantly lower in constipation patients than in controls. The maximal SC response to repetitive maximal distensions was higher in IBS patients compared with constipation patients. The amplitude of the initial SC response decreased successively with increased number of distensions in patients with IBS and constipation but not in controls. Irritable bowel syndrome and constipation patients habituated to maximal repetitive rectal distensions with decreasing sympathetic activity. Irritable bowel syndrome patients had higher sympathetic reactivity and baseline activity than constipation patients. A lower basal SC in constipation patients compared with controls suggests an inhibition of the sympathetic drive in constipation patients.

Increase of serum C-reactive protein is an early indicator of subsequent symptomatic anastomotic leakage after anterior resection.

OBJECTIVE: This prospective study investigated the factors which might indicate anastomotic leakage after low anterior resection. METHOD: Thirty-three patients who underwent anterior resection for rectal carcinoma (n = 32) and severe dysplasia (n = 1), were monitored daily by serum C-reactive protein (CRP) and white blood cell count (WBC) estimations until discharge from hospital. Computed tomography (CT) scans were performed on postoperative days 2 and 7 and the amount of presacral fluid collection was assessed. All patients had a pelvic drain and the volume of drainage was measured daily. RESULTS: The level of the anastomosis was at a median 5 cm (3-12 cm) above the anal verge. There was no 30-day mortality. Nine (27.2%) of the 33 patients developed a symptomatic anastomotic leakage which was diagnosed at a median of 8 days (range 4-14) postoperatively. The serum CRP was increased in patients who leaked from postoperative day 2 onwards (P = 0.004 on day 2; P < 0.001 on day 3-8). The WBC was decreased in preoperatively irradiated patients on days 1-5 (P

Costs and resource use following defunctioning stoma in low anterior resection for cancer - A long-term analysis of a randomized multicenter trial.

BACKGROUND: Defunctioning stoma in low anterior resection (LAR) for rectal cancer can prevent major complications, but overall cost-effectiveness for the healthcare provider is unknown. This study compared inpatient healthcare resources and costs within 5 years of LAR between two randomized groups of patients undergoing LAR with and without defunctioning stoma. METHOD: Five-year follow-up of a randomized, multicenter trial on LAR (NCT 00636948) with (stoma; n = 116) or without (no stoma; n = 118) defunctioning stoma comparing inpatient healthcare resources and costs. Unplanned stoma formation, days with stoma, length of hospital stay, reoperations, and total associated inpatient costs were analyzed. RESULTS: Average costs were € 21.663 per patient with defunctioning stoma and € 15.922 per patient without defunctioning stoma within 5 years of LAR, resulting in an average cost-saving of € 5.741. There was no difference between groups regarding the total number of days with any stoma (stoma = 33 398 vs. no stoma = 34 068). The total number of unplanned reoperations were 70 (no stoma) and 32 (stoma); p < 0.001. In the group randomized to no stoma at LAR, 30.5% (36/118) required an unplanned stoma later. CONCLUSION: Randomization to defunctioning stoma in LAR was more expensive than no stoma, despite the cost-savings associated with a reduced frequency of anastomotic leakage. Both groups required the same total number of days with a stoma within five years of LAR.

Pre-experimental stress in patients with irritable bowel syndrome: high cortisol values already before symptom provocation with rectal distensions.

Stress is known to affect symptoms of irritable bowel syndrome (IBS) probably by an alteration of visceral sensitivity. We studied the impact of maximal tolerable rectal distensions on cortisol levels in patients with IBS, chronic constipation and controls, and evaluated the effect of the experimental situation per se. In twenty-four IBS patients, eight patients with chronic constipation and 15 controls salivary cortisol was measured before and after repetitive maximal tolerable rectal balloon distensions and at similar times in their usual environment. Rectal sensitivity thresholds were determined. IBS patients but not controls and constipation patients had higher cortisol levels both before and after the experiment compared with similar times on an ordinary day in their usual environment (P = 0.0034 and 0.0002). There was no difference in salivary cortisol level before compared with after rectal distensions. The IBS patients had significantly lower thresholds for first sensation, urge and maximal tolerable distension than controls (P = 0.0247, 0.0001 and <0.0001) and for urge and maximal tolerable distension than patients with constipation (P = 0.006 and 0.013). IBS patients may be more sensitive to expectancy stress than controls and patients with constipation according to salivary cortisol. Rectal distensions were not associated with a further significant increase in cortisol levels.

Nodal involvement in luminal complete response after neoadjuvant treatment for rectal cancer.

BACKGROUND: Pathological complete response (pCR) after neoadjuvant therapy in rectal cancer is correlated with improved survival. There is limited knowledge on the incidence of pCR at a national level with uniform guidelines. The aim of this prospective register-based study was to investigate the incidence and outcome of pCR in relation to neoadjuvant therapy in a national cohort. METHOD: All patients abdominally operated for rectal cancer between 2007 and 2012 (n = 7885) were selected from The Swedish Colo-rectal Cancer Register. Twenty-six per cent (n = 2063) had neoadjuvant therapy with either long or short course radiotherapy with >4 weeks delay with the potential to achieve pCR. The primary endpoints were pCR and survival in relation to neoadjuvant therapy. RESULTS: Complete eradication of the luminal tumor, ypT0 was found in 161 patients (8%). In 83% of the ypT0 the regional lymph nodes were tumor negative (ypT0N0), 12% had 1-3 positive lymph nodes (ypT0N1) and 4% had more than three positive lymph nodes (ypT0N2). There was significantly greater survival with ypT0 compared to ypT+ (hazard ratio 0.38 (C.I 0.25-0.58)) and survival was significantly greater in patients with ypT0N0 compared to ypT0N1-2 (hazard ratio 0.36 (C.I 0.15-0.86)). In ypT0, cT3-4 tumors had the greater risk of node-positivity. The added use of chemotherapy resulted in 10% ypT0 compared to 5.1% in the group without chemotherapy (p < 0.00004). CONCLUSION: Luminal pathological complete response occurred in 8%, 16% of them had tumor positive nodes. The survival benefit of luminal complete response is dependent upon nodal involvement status.

Clinical consequences of anal sphincter rupture during vaginal delivery.

BACKGROUND: Rupture of the anal sphincters at childbirth is considered rare in obstetric literature. Long-term effects are sparingly mentioned. In clinical practice, however, it is not uncommon to meet women with anal incontinence. The aim of our study was to record the incidence and to evaluate the consequences of rupture of the anal sphincter at childbirth. STUDY DESIGN: Fifty-one consecutive women with primarily sutured anal sphincter rupture and 31 women without anal sphincter rupture were prospectively studied after vaginal delivery. All were assessed clinically at 3 days, 6 weeks, and 6 months after delivery. After 6 months, all women underwent anorectal manometry and answered a questionnaire about incontinence, social function, and general health. RESULTS: The overall incidence of sphincter rupture was 2.4 percent. Significantly lower values were found for maximum anal squeeze pressure and squeeze pressure area 6 months postpartum in the women with sphincter rupture compared with those without rupture. The resting pressures did not differ between groups. Approximately 40 percent of the women in both groups had noted some fecal incontinence by 6 months postpartum. Symptoms were significantly more severe in patients with sphincter rupture. CONCLUSIONS: Anal sphincter rupture was 2.4 times as common as reported in Swedish birth statistics. The high incidence of fecal incontinence by 6 months postpartum in all women is surprising and deserves further investigation, specifically regarding occult sphincter rupture.

Safety of the temporary loop ileostomy.

OBJECTIVE: To evaluate the complications of the temporary loop ileostomy. METHOD: A retrospective study of 222 consecutive patients with low anterior resection, ileal pouch-anal anastomosis or continent ileostomy and a diverting loop ileostomy routinely fashioned during the primary operation. The loop ileostomy was closed in 213 patients (96%) during the minimum follow-up period of 15 months. RESULTS: Four patients (2%) required preterm closure of the ostomy due to stomal retraction (n = 3) or bowel obstruction (n = 1). Four patients were readmitted due to transient bowel obstruction that resolved without surgery. After closure of the loop ileostomy a total of 27 patients (13%) had complications. In 7 patients emergency re-operation was done due to small bowel obstruction (n = 5) or intra-abdominal abscess (n = 2). Elective re-operation was done in 5 patients for hernia at the site of the previous stoma. Despite the use of a loop ileostomy there was 1 postoperative death after the initial operation in consequence of anastomotic leakage. There was 1 death in consequence of closure of the loop ileostomy after 3 weeks due to intra-abdominal sepsis and heart failure. CONCLUSION: In this series closure of the ostomy wasassociated with one death (0.5%) and overall ostomy-related morbidity included the need to re-operate in 6%.

Vulvar vestibulitis syndrome and vaginismus. A case report.

BACKGROUND: Recent reports have argued for a revision of the criteria used for the establishment of a diagnosis of vulvar vestibulitis syndrome (VVS). On theoretical grounds it might be hypothesized that women with VVS also suffer from vaginismus. CASE: A young woman presented with a history, symptoms and objective findings typical of vaginismus, yet she suffered from continuous, burning pain and itching in the vestibule. Earlier in the course of the problem she had received a diagnosis VVS. The patient was treated with behavioral therapy developed for vaginismus. Notations made during the course of therapy supported the assumption that the pain and itching were conditioned responses to penetration in the same way that a vaginal muscular reflex is. CONCLUSION: Differential diagnostic difficulties exist in the field of VVS and vaginismus. Psychophysiologic theories are needed as the basis for research to clarify the connections between different diagnostic entities associated with coital burning pain and itching in the vestibule.

Outcome of 132 consecutive reconstructive operations for intestinal fistula--staged operation without primary anastomosis improved outcome in retrospective analysis.

AIM: To study factors that influenced healing and survival after attempted closure of enterocutaneous fistula. MATERIAL AND METHODS: Retrospective analysis of prospective data concerning 101 patients operated on 132 instances for 110 enterocutaneous fistulae at two hospitals. RESULTS: In all, 96 (87%) of the 110 fistulae healed and 92 (91%) patients survived. A total of 9 patients with unhealed fistula died. Multivariate analysis revealed jaundice as an independent factor for both death and failed closure and operation without anastomosis as an independent positive factor for healing. Failure rate was lower after an operation with stoma without anastomosis (6 of 43, 14%) than after an operation with anastomosis (30 of 89, 34%) p = 0.0213. Of the 36 instances with unhealed fistula, 13 (36%) could be ascribed to inadvertent bowel lesions at the reconstructive operation. In addition, univariate analysis revealed that patients with previous multiple laparotomies or with multiple operations for enterocutaneous fistula healed less likely and had higher mortality. A low serum albumin, high white blood cell count, high C-reactive protein concentration, high fistula output, total parenteral nutrition, and operation for recurrent fistula were associated with death together with long operation time and operative bleeding, both indicators of surgical complexity. Over time, staged surgery avoiding anastomosis increased from 27% to 57%. Mortality decreased from 12% to 6%, and healing increased from 73% to 94%. CONCLUSIONS: Chronic inflammation, malnutrition, and liver failure causing an impaired healing capacity are important reasons for failure. Staged operation without primary anastomosis may allow the patient to reverse this condition and improve outcome. The high surgical complexity is a negative factor that requires careful planning of the operation.

Population-based study of risk factors for postoperative death after anterior resection of the rectum.

BACKGROUND: The aim of this population-based study was to analyse risk factors for death within 30 days after anterior resection of the rectum. METHODS: Between 1987 and 1995 a total of 6833 patients underwent elective anterior resection of the rectum in Sweden. One hundred and forty of these patients died within 30 days or during the initial hospital stay. These patients were compared with a randomly chosen cohort of 423 patients who underwent the same operation during the same interval, and were alive after 30 days and discharged from hospital. The association between death and 12 putative risk factors was studied. RESULTS: The mortality rate after elective anterior resection was 2.1 per cent (140 of 6833). The incidence of clinical anastomotic leakage was 42.1 per cent (59 of 140) among those who died and 10.9 per cent (46 of 423) in the cohort group. Multivariate regression analysis identified clinical leakage, increased age, male sex, Dukes' 'D' stage and intraoperative adverse events as independent risk factors for death within 30 days. CONCLUSION: Clinical anastomotic leakage was a major cause of postoperative death after anterior resection.

Surgical approaches to obtaining optimal bowel function.

Approximately 50% of patients have an unsatisfactory functional result after traditional restorative rectal resection, and an even higher percentage, at least in the early postoperative period, suffers from urgency, frequent bowel movements, and occasional faecal incontinence. The rectal reservoir function is disturbed after restorative surgery. This is related to the size of the rectal remnant, the viscero-elastic properties, and the motility pattern of the neorectal wall, because segments of the remaining colon can only substitute for the rectum to a limited extent. A straight anastomosis is recommended when the rectal remnant (measured from the anal verge) is at least 7 to 8 cm. The side-to-end anastomosis is probably preferable to the end-to-end anastomosis. In contrast, a straight anastomosis at the levator plane cannot be recommended. If straight anastomosis is still considered, the descending colon should be used rather than the sigmoid colon. The colonic pouch was introduced to increase the neorectal volume and eliminate some of the functional disturbance associated with the reduced neorectal volume occurring after a straight colo-anal anastomosis. To obtain optimal functional results soon after surgery, a pouch should be used when the anastomosis is located 3 to 5 cm from the anal verge. The size of the pouch should not be too small. A staple line of 6 to 7 cm is a fair compromise between the low anterior resection syndrome and problems with evacuation. Since the descending colon has a thinner wall and often is healthier than the sigmoid colon, it should be the first choice for the anastomosis.

Anastomotic leakage and functional outcome after anterior resection of the rectum.

Nineteen patients with symptomatic anastomotic leakage after anterior resection were compared with 19 without leakage. The two groups were closely matched according to age, sex, height of anastomosis and follow-up. No patient had any sign of anastomotic stricture or neoplastic recurrence at the time of the study. After a median of 30 (range 12-87) months there was no difference in sphincter function as measured by manometry. 'Neorectal' volume at distension pressures of 40 and 50 cmH2O and compliance at sensation of filling, urge to defaecate and maximum tolerated volume were significantly reduced in patients with leakage. This reduction in neorectal reservoir function was reflected in impaired anorectal function, measured by a combination of: (1) frequency of bowel movements; (2) degree of urgency; (3) incontinence score; and (4) degree of impaired evacuation. Long-term functional outcome may be impaired by anastomotic leakage.