COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. TRIAL DESIGN: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

[Breast reduction surgery. County of Velje--a 12-year follow-up study]. / Mammareduktionsplastik. Vejle Amt--en 12 års opgørelse.

A questionnaire investigation of 299 women treated operatively over a 12-year period for breast hypertrophy in four general surgical units is presented. Different surgical techniques were used, and in one of the departments one plastic surgeon performed the operations. The results of the different techniques were compared. All techniques gave good physical relief. Pers & Bretteville-Jensen's technique proved to be better in maintaining the sensitivity of the nipple, but a higher incidence of complications occurred. With McKissock's, Strömbeck's and Bames-Ragnell's techniques all scars end up looking like an anchor. These methods are preferred by most women, in spite of a higher risk of losing the sensitivity of the nipple. Significantly more women who had undergone reduction mammaplasty with the Pers & Bretteville-Jensen technique, which ends up with a horizontal scar across the breast, regretted the operation. The cosmetic results were very important for the patients, and a more uniform treatment of the patients might be preferred.

Outcome at three to five years of primary closure of perianal and pilonidal abscess. A randomised, double-blind clinical trial with a complete three-year followup of one compared with four days' treatment with ampicillin and metronidazole.

OBJECTIVE: To evaluate the long term results after primary closure of perianal abscess and pilonidal sinus. DESIGN: Follow up by questionnaire and study of casenotes. SETTING: University hospital and district hospital. SUBJECTS: 88 Patients who had previously been in a prospective random control trial of two regimens of antibiotic treatment (ampicillin and metronidazole for one compared with four days) before incision, curettage, and primary closure of perianal abscess or pilonidal sinus. MAIN OUTCOME MEASURES: Recurrence rate and outcome. RESULTS: 32 Patients had perianal abscesses of which 31 (97%) healed primarily (95% confidence interval [CI] 84 to 100%) with 4 recurrences (13%, 95% CI 2 to 24%). 56 Patients had pilonidal sinuses or abscesses of which 46 (82%) healed primarily (95% CI 70 to 91%) with 14 recurrences (30%, 95% CI 16 to 40%). There were no significant differences between the two antibiotic regimens. The mean followup was 53 months. Two patients had died, both had had perianal abscesses. Pilonidal sinuses tended to recur during the first year, whereas pilonidal abscesses recurred after a lapse of two years or more. Half the patients who had had previous operations for the same complications, compared with a third who were being operated on for the first time. CONCLUSIONS: A one day course of ampicillin and metronidazole is not associated with any more complications than a four day course. Perianal abscesses respond well to primary closure, but management of pilonidal abscesses and sinuses is more difficult.

[Early resuturing after abdominal wound infection under prophylactic metronidazole and ampicillin]. / Tidlig resutur efter abdominal sårinfektion under daekke af metronidazol og ampicillin.

A randomized double-blind investigation was undertaken to assess the effect of treatment with metronidazole and ampicillin in patients with subcutaneous wound infection after laparotomy and early resuture. The wounds were closed in the fourth day and the antibiotic cover lasted from one to four days. None of the patients developed signs of sepsis or new abscesses. All of the wounds healed primarily but there were slight defects in two patients. These did not require surgical treatment. It is concluded that early closure of infected wounds after laparotomy may be undertaken under metronidazole and ampicillin cover and that treatment for one day is sufficient.

Bactericidal antimicrobial cover in primary suture of perianal or pilonidal abscess. A prospective, randomized, double-blind clinical trial.

The effect of 1-day treatment vs. 4-day treatment with metronidazole and ampicillin in association with primary closure of perianal and pilonidal abscesses was evaluated in a double-blind clinical trial. The patients were randomly allocated to 1-day (group I) or 4-day (group II) antibiotic regimen. No clinical signs of sepsis appeared in any patient. Primary healing, without fistula formation was achieved in all 17 perianal abscesses in the 1-day therapy group and in 14 of 15 in the 4-day group (non-significant difference). Excision with primary suture of pilonidal abscess resulted in primary healing in 20 of 26 cases in group I and 20 of 30 in group II (non-significant difference). Healing with formation of a new sinus or secondary healing occurred in four and two cases, respectively, in the 1-day therapy group, and in two and nine of the 4-day group. One-day administration of metronidazole/ampicillin is as effective as 4-day treatment in primary closure of perianal and pilonidal abscess. The procedure appears to be safe in both groups, but more efficacious in perianal abscess.

Significance of the extent of transurethral prostatic resection for postoperative complications.

The significance of the extent of transurethral prostatic resection for benign prostatic hypertrophy was evaluated as regards early and late postoperative complications in a prospective, randomized study. The two treatment groups were preoperatively comparable in age, incidence of urinary retention and estimated prostatic weight. In 83 cases the median weight of resected tissue was 18 (range 4-118) g, while in 84 cases the resection was less extensive--median weight 7 (1-40) g. No significant intergroup difference was found in incidence of bladder tamponade, bladder perforation, urinary tract infection or pneumonia. The blood transfusion need was greatest among the patients with complete transurethral adenomectomy of the prostate. Concerning late postoperative complications, the groups did not differ in incidence of urethral stricture, bladder neck contracture or reoperation for benign prostatic hypertrophy. Patients with preoperative urethral instrumentation had heightened risk of developing postoperative urethral stricture.

The significance of age on symptoms and urodynamic- and cystoscopic findings in benign prostatic hypertrophy.

To evaluate influence of age on symptomatology and objective parameters in benign prostatic hypertrophy, preoperative findings in 199 unselected patients during one year were analysed. Symptoms of bladder instability increased with age, as did incidence of uninhibited detrusor contractions and bladder trabeculation, whereas maximum urine flow and obstructive complaints decreased, although prostatic size was the same. In the oldest age groups only was increasing prostatic size associated with increasing bladder trabeculation. Age related changes in neurological control and in the structure of the bladder may be involved, and the present results suggest age to be an important factor in the interpretation of symptoms and objective findings in prostatic hypertrophy.

Sexual life following 'minimal' and 'total' transurethral prostatic resection.

81 otherwise healthy men with an average age of 67 years and verified prostatic hypertrophy were randomized into two groups for either 'minimal' or 'total' transurethral prostatic resection (TUR-P). Interviews on sexual life were made preoperatively and 6 and 12 months postoperatively. 58 men (72%) were prior to the operation sexually active. 18 (31%), mainly men of advanced age, discontinued sexual activity following TUR-P. 40 (69%) remained active. 19 had retrograde ejaculation. No significant difference was found between 'minimal' and 'total' TUR-P concerning the effect on sexual activity and the occurrence of retrograde ejaculation.

Cystadenoma of the seminal vesicle. A case report.

Cystadenomas of the seminal vesicle are extremely rare benign tumours, which only have been reported seven times earlier in the literature. The first Danish case is reported with discussion of symptomatology, pathology and treatment.