Parameters predicting postoperative pain and quality of life after hemorrhoidectomy: follow-up results from a prospective multicenter randomized trial.

PURPOSE: Pain and reduced quality of life (QoL) are major subjects of interest after surgery for hemorrhoids. The aim of this study was to find predictive parameters for postoperative pain and QoL after hemorrhoidectomy. METHODS: This is a follow-up analysis of data derived from a multicenter randomized controlled trial including 770 patients, which examines the usefulness of tamponade after hemorrhoidectomy. Different pre-, intra-, and postoperative parameters were correlated with pain level assessed by NRS and QoL by the EuroQuol. RESULTS: At univariate analysis, relevant (NRS > 5/10 pts.) early pain within 48 h after surgery was associated with young age (≤ 40 years, p = 0.0072), use of a tamponade (p < 0.0001), relevant preoperative pain (p = 0.0017), pudendal block (p < 0.0001), and duration of surgery (p = 0.0149). At multivariate analysis, not using a pudendal block (OR 2.64), younger age (OR 1.55), use of a tamponade (OR 1.70), and relevant preoperative pain (OR 1.56) were significantly associated with relevant early postoperative pain. Relevant pain on day 7 was significantly associated only with relevant early pain (OR 3.13, p < 0.001). QoL overall remained at the same level. However, n = 229 (33%) patients presented an improvement of QoL and n = 245 (36%) an aggravation. Improvement was associated with a reduction of pain levels after surgery (p < 0.0001) and analgesia with opioids (p < 0.0001). CONCLUSION: Early relevant pain affects younger patients but can be prevented by avoiding tamponades and using a pudendal block. Relevant pain after 1 week is associated only with early pain. Relief in preexisting pain and opioids improve QoL. TRIAL REGISTRATION: DRKS00011590 12 April 2017.

Tamponade dressing versus no dressing after haemorrhoidectomy: multicentre, randomized clinical trial.

BACKGROUND: Symptomatic haemorrhoids are a common anorectal disorder. The aim of the study was to investigate whether the omission of tamponade dressings after haemorrhoidectomy reduces postoperative pain without increasing the risk of severe bleeding. METHOD: This was an open-label, randomized clinical trial conducted at 14 German hospitals. All patients with third- or fourth-degree haemorrhoids undergoing haemorrhoidectomy were considered eligible for selection in the intervention (no dressing) or control group (tamponade applied). Two co-primary outcomes were analysed by testing hierarchically ordered hypotheses. First, maximum pain intensity within 48 h after surgery was compared between the groups (superiority). This was followed by an analysis of severe bleeding complications, defined as any bleeding requiring surgical re-intervention within 7 days (non-inferiority). Secondary outcomes included health-related quality of life, patient satisfaction, haemoglobin levels, and adverse events. RESULTS: Out of 950 patients screened, 754 were randomized and 725 received intervention (366 patients in the intervention and 359 patients in the control group). In the group with tamponade dressings, median pain intensity on the 0 to 10 scale was 6 (interquartile range (i.q.r.) 4-7). Patients without tamponade dressings reported significantly less pain (median 5 (i.q.r. 3-7), P < 0.001). In each group, five patients (1.4 per cent) experienced severe bleeding. The absolute difference for the severe bleeding rate was -0.03 per cent with the 90 per cent confidence interval ranging from -1.47 per cent to +1.41 per cent, in line with the non-inferiority aim. No significant between-group difference was found for secondary outcomes. CONCLUSIONS: The practice of inserting tamponade dressings after haemorrhoidectomy correlates with increased postoperative pain and does not provide benefits in terms of reduced postoperative bleeding. REGISTRATION NUMBER: DRKS00011590.

Active aspiration versus simple compression to remove residual gas from the abdominal cavity after laparoscopic cholecystectomy: a randomized clinical trial.

PURPOSE: After laparoscopic surgical procedures, residual gas in the abdominal cavity can cause post-operative pain, which is commonly located in the shoulder region. Previous studies suggested that post-laparoscopy pain can be prevented by active suctioning of intraabdominal gas at the end of surgery. METHODS: This randomized controlled trial (registered at DRKS 00,023,286) compared active suctioning versus manual compression in their ability to reduce pain after laparoscopic cholecystectomy. Patients scheduled for laparoscopic cholecystectomy were eligible for trial participation. The primary outcome measure was post-operative pain intensity after 12 h. All the patients were examined by MRI scanning to quantify the intraabdominal gas volume after the intervention. RESULTS: As planned, 60 patients were recruited. The two groups (n = 30 each) were very similar at the end of surgery. Active suctioning reduced the amount of residual pneumoperitoneum more than simple compression (median volume 1.5 versus 3.0 ml, p = 0.002). The primary outcome measure, abdominal pain after 12 h, was slightly lower in the intervention group (- 0.5 points, 95% confidence interval + 0.5 to - 1.7), but without reaching statistical significance (p = 0.37). After 12 h, shoulder pain was present in 10 patients in each group (p = 1.0). Independent of group assignment, however, residual gas volume was significantly associated with higher pain intensity. CONCLUSIONS: Active suctioning appears to have only a minor preventive effect on post-laparoscopy pain, probably because evacuation of the pneumoperitoneum remains incomplete in some patients. Other more effective maneuvers for gas removal should be preferred.

Use of plastic adhesive skin drapes in cancer patients undergoing totally implantable vascular access port (TIVAP) placement-a randomized controlled pilot study.

PURPOSE: A totally implantable vascular access port (TIVAP) is commonly required in cancer patients. Possible adverse events after TIVAP implantation include surgical site infection (SSI) and port-related bacteremia. This study examined whether adhesive surgical drapes can reduce the risk of SSI. METHODS: A total of 100 mostly cancer patients were randomized into two groups before undergoing TIVAP implantation by surgical cut-down. In one group, an adhesive, non-impregnated drape was applied to the skin prior to incision, while the control group underwent surgery without a drape. Swabs were taken from the surgical site and sent for microbiologic testing. SSI rates were compared between groups. RESULTS: No SSI occurred within 30 days after surgery. In each group, two patients died. There were 5 complications (port thrombosis, port dislocation, two cases of pneumothorax, skin allergy), all in the intervention group (p = 0.056). Using the incision drape prolonged procedure time by + 5 min (95% CI - 1 to + 10, p = 0.125). Microbiologic swab testing failed to detect any effect of the incision drape. CONCLUSIONS: Plastic adhesive skin drapes may be unnecessary in cancer patients who undergo surgical implantation of a TIVAP.

Efficacy of conservative treatment of perianal abscesses in children and predictors for therapeutic failure.

BACKGROUND: The optimal management of perianal abscess in children is controversial. PURPOSE: To evaluate the efficiency of conservative treatment of perianal abscess in children and identify parameters that predict therapy failure. METHODS: All cases of children younger than 14 years of age with perianal abscesses between 2001-2016 were evaluated. RESULTS: Of the 113 enrolled patients, 64 underwent subsequent surgery for advanced disease (primary surgery group). Conservative treatment was initiated in 49 patients (primary conservative group) but was stopped because of inefficiency in 25 patients, who were referred for surgery after a median 7.03 days (range, 2 to 16 days). The other 24 patients (48%) initially achieved complete remission after conservative treatment, but 10 were readmitted after a median 34 months (range, 3 to 145 months) with recurrent disease. There were no significant differences in permanent success after conservative treatment between infants (10 of 29, 34%) and older children (4 of 20 [20%], P=0.122). Overall, conservative treatment alone was effective in only 14 of 113 patients. Recurrence after surgery occurred in 16 patients (25%) in the primary surgery group and 11 patients (22%) in the primary conservative group (P=0.75). Univariate analysis of predictors for conservative treatment failure revealed inflammatory values (C-reactive protein and white blood count, P=0.017) and abscess size (P=0.001) as significant parameters, whereas multivariate analysis demonstrated that only abscess size (odds ratio, 3.37; P=0.023) was significant. CONCLUSION: Conservative treatment of perianal abscess is permanently efficient in only a minority of children but is not associated with a higher recurrence rate after subsequent surgery. Abscess size is a predictor for therapy failure.

Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.

After publication of the original article [1], the authors have notified us that their originally submitted Table 1 was mistakenly replaced with Fig. 3 during editing. The original article has been corrected.The publisher apologizes to the readers for the inconvenience caused.

Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.

BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan-Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp. METHODS: We plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage ( https://notamp.de/en-GB/trial/main/setLocale/en_GB/ ). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590 . Registered on 12 April 2017.

Tamponade dressings may be unnecessary after haemorrhoidectomy: a randomised controlled clinical trial.

PURPOSE: Bleeding after haemorrhoidectomy is common. Many surgical textbooks recommend insertion of an anal tampon in order to reduce postoperative bleeding. This practice, however, is bothersome and probably painful for patients. The effect of using a tamponade has not been validated in randomised controlled trials. METHODS: The study included 100 patients who were scheduled for Milligan-Morgan haemorrhoidectomy. During surgery, patients were randomly assigned to receive or not to receive an anal tampon at the end of the procedure. Data on pain, complications and wound care were collected. The trial was registered (DRKS00003116) and all analyses were by intention-to-treat. RESULTS: There were 48 patients in the group with tamponade, and 52 patients were left without tamponade. The trial's primary outcome and maximum pain intensity, averaged 6.1 and 4.2 in the two groups (P = 0.001). In the group with tamponade, a complication was recorded in seven patients (15 %), which was similar to the group without tamponade (21 %). Severe anal bleeding occurred in two and five patients, respectively. Bandage changes were less necessary often in the group treated without tamponade (P = 0.013). Hospital stay was 4 days in both groups. CONCLUSIONS: Data indicate that insertion of an anal tampon after haemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. After haemorrhoidectomy, anal tampons should not be used routinely but may be considered when specific indications justify its use.

Why so late?!--delay in treatment of colorectal cancer is socially determined.

PURPOSE: The interval between symptom onset and therapy in patients with colorectal cancer was studied. METHODS: One hundred twenty three patients with colorectal cancer were included. Demography data, symptoms, consultations, and tumour stage were obtained by standardized questionnaires. Risk factors for delayed treatment were analysed. RESULTS: Eighty six patients suffered from colonic cancer. The total time between the first symptoms and therapy ranged from 13 to 442 days (mean, 148). Delay of surgical therapy was responsible for significantly higher tumour grades. Delayed start of therapy was found to be correlated to the type of cancer, socioeconomic status, marital status, and quality of first consultation (univariate analysis). On multivariate analyses, type of cancer, marital and socioeconomic status remained significantly associated with delayed treatment (all p values ≤ 0.001, r(2) = 0.50). CONCLUSIONS: The delay in treatment of colorectal cancer depends on socioeconomic status and family background. Achieving equity in colorectal cancer detection may require consideration of high-risk subgroups.

Sixty-month follow-up after endoscopic inguinal hernia repair with three types of mesh: a prospective randomized trial.

BACKGROUND: This prospective, clinical, randomized, double-blind study was intended to investigate the impact of the structure and the amount of polypropylene (PP) mesh used in laparoscopic transabdominal preperitoneal hernioplastic (TAPP) on physical function and life quality. METHODS: 180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m(2)), double-filament PP mesh (Prolene, 10 x 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m(2)) of PP mesh (Serapren, 10 x 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 x 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate) and life quality (pain development, physical function). The development of life quality was documented according to the SF-36 Health Survey. The follow-up period was 60 months. RESULTS: The recurrence rate (2.2% overall) during 60-month follow-up was not significantly different between the groups. Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th postinterventional week the differences diminished. CONCLUSIONS: The composite mesh does not provide an advantage concerning physical function or pain development in comparison to the multifilament, heavyweight, pure polypropylene mesh. Independently of which mesh was implanted 5% of patients are still suffering from discomfort after 5 years.

Delay in treatment of colorectal cancer: multifactorial problem.

The stage of a colorectal carcinoma represents the most important prognostic factor regarding the probability of survival. The primary objective of this study was to document the management of patients with colorectal carcinoma after onset of symptoms. Factors influencing the delay in definitive therapy should thus be determined. Anthropometric, social, and operative data were obtained by standardized questionnaires from 40 patients with colonic cancer and 30 patients with rectal cancer. The influence of delayed treatment on outcome was analyzed. A significant correlation was found for the time between onset of first symptoms and definitive surgical therapy with tumor stage (colon cancer: r = 0.52, p < 0.05; colorectal cancer: r = 0.62, p < 0.05). The time delay in rectal carcinoma patients averaged 224 days and in patients with colonic carcinoma 149 days. Social influences such as profession, type of education, marital status, and quality of health insurance had a significant influence on treatment delay, as did the clinical experience of the physician first contacted. The leading symptom in patients with rectal cancer was peranal hemorrhage, and in patients with colonic cancer it was abdominal pain. The main causes of iatrogenic delay were insufficient clinical investigation and a lack of awareness when typical first symptoms were present. Delayed treatment of colorectal cancer seems to be a multifactorial problem. Causes for such delay are found not only in the patients and their social environments but also in the type and quality of their medical care systems. Intensified education and earlier prevention are the major aims for patients and their physicians.