Complications associated with two laparoscopic procedures used in the management of rectal endometriosis.

BACKGROUND: To evaluate intra- and postoperative complications associated with laparoscopic management of rectal endometriosis by either colorectal segmental resection or nodule excision. METHODS: During 39 consecutive months, 46 women underwent laparoscopic management of rectal endometriosis and were included in a retrospective comparative study. The distinguishing feature of the study is that the choice of the surgical procedure is not related to the characteristics of the nodule. RESULTS: Colorectal segmental resection with colorectal anastomosis was carried out in 15 patients (37%), while macroscopically complete rectal nodule excision was performed in 31 women (63%). No intraoperative complications were recorded. In the colorectal resection group, 3 women (18%) had a bladder atony (spontaneously regressive in 2 women), 4 women (24%) experienced chronic constipation, one had an anastomosis leakage (6%), while 2 women (13%) had acute compartment syndrome with peripheral sensory disturbance. In the nodule excision group, 1 woman (4%) developed transitory right obturator nerve motor palsy. Based on both postoperative pain and improvement in quality of life, all 29 women in the excision group (100%) and 14 women in the colorectal resection group (82%) would recommend the surgical procedure to a friend suffering from the same disease. CONCLUSION: Our study suggests that carrying out colorectal segmental resection in rectal endometriosis is associated with unfavourable postoperative outcomes, such as bladder and rectal dysfunction. These outcomes are less likely to occur when rectal nodules are managed by excision. Information about complications related to both surgical procedures should be provided to patients managed for rectal endometriosis and should be taken into account when a decision is being made about the most appropriate treatment of rectal endometriosis in each case.

Reporting on quality of life in randomised controlled trials in gastrointestinal surgery.

BACKGROUND: Although health-related quality of life (HRQOL) has become an important outcome measure in surgical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate HRQOL assessment methodology of randomised clinical trials concerning gastrointestinal surgery. METHODS: All articles published in the calendar years 2006 and 2007 that purported to assess quality of life as end points or make some conclusion about quality of life were chosen for review from eight general surgical journals and four medical journals. Identified eligible studies were selected and then evaluated on a broad set of predetermined criteria. RESULTS: Twenty-four published randomised controlled clinical trials (RCTs)s with an HRQOL component were identified. Although most trials exhibited good-quality research, some methodological limitations were identified: Only 21% of the studies gave a rationale for selecting a specific HRQOL measure, 46% of the studies failed to report information about the administration of the HRQOL measure, and 37% did not give details on missing data. CONCLUSIONS: Although it is clear that HRQOL is an important end point in surgical RCTs because the information helps to influence treatment recommendations, a number of methodological shortcomings have to be further addressed in future studies.

Prognostic value of circulating mutant DNA in unresectable metastatic colorectal cancer.

OBJECTIVE: No validated biologic prognostic marker is presently available in metastatic colorectal cancer (MCRC). We prospectively evaluated the prognostic value of circulating mutant DNA in 31 patients presenting an unresectable MCRC treated by chemotherapy, and we used, as tumor markers, KRAS mutations and methylation of the RASSF2A promoter. METHODS: Detection in the serum of KRAS mutation and RASSF2A methylation were performed using sensitive methods, respectively, real-time polymerase chain reaction (PCR) performed in the presence of a peptide nucleic acid specific of the wild-type sequence and methyl-specific PCR after bisulfite treatment. RESULTS: Among 29 MCRC patients for whom DNA from the primary tumor was available, 23 (79%) presented at least one of the markers in their primary tumor, and 12 of them presented the same alteration in serum. For the 2 remaining patients, RASSF2A methylation was detected in serum indicating that this alteration was present in the primary tumor. These 14 patients with a detectable tumor marker in their serum were designed sDNA+ patients. After 6 months of follow-up, 11/14 (79%) sDNA+ and 1/11 (9%) sDNA- patients presented a progressive disease (P = 0.001). The median progression free survival was 5 months in sDNA+ patients versus 14 months in sDNA- patients (P = 0.004). After 1 year of follow-up, 2 of 14 (14%) sDNA+ and 8 of 11 (73%) sDNA- patients presented no signs of disease progression (P = 0.005). CONCLUSIONS: This study suggests that the presence of circulating mutant DNA in unresectable MCRC patients, which can be detected using simple methods such as methylation-specific PCR or real-time PCR, is highly predictive of clinical outcome.

Constipation in 44 patients implanted with an artificial bowel sphincter.

PURPOSE: Constipation with or without obstructed defecation (OD) is frequent in patients with artificial bowel sphincter (ABS). The aims of this study were (1) to evaluate the functional outcome of ABS based on postoperative constipation and (2) to assess pre-implantation data to predict post-implantation constipation. MATERIALS AND METHODS: Thirteen men and 31 women were followed up. Both fecal incontinence and constipation with and without OD were assessed after implantation. Pre-implantation characteristics were compared in patients with and without postoperative constipation. RESULTS: After implantation, nine patients (20.4%) had constipation without OD, 16 patients (36.4%) had OD, and 19 patients (43.2%) had neither of these. Incontinence was significantly more frequent in patients with postoperative constipation with or without OD. In these patients, an increase in preoperative constipation, anismus, and ultraslow waves was noted. CONCLUSION: Constipation with and without OD is frequent after implantation and interfere with the functional outcome of ABS.

Methodological and ethical quality in phase III--breast cancer trials.

OBJECTIVE: The gold standard of Evidence Based Medicine remains the randomised controlled trial (RCT), which is the only tool that allows an approach to the "therapeutic truth". To reach credible conclusions, these trials need to be perfect in methodological and ethical quality. The purpose of this study is to evaluate methodological quality (MQ), ethical quality (EQ) and compliance with ethical requirements in phase III randomized clinical trials of breast cancer treatment. STUDY DESIGN: MQ was evaluated by the Jadad-scale and EQ by the Berdeu-score for all the randomised controlled clinical trials (RCT) (n = 137), published between January 2001 and December 2005 in 11 international journals. RESULTS: Mean MQ was 9.88 +/- 1.43. MQ was insufficient (Jadad score pound 9) for 49 RCT (35,8%). Mean EQ was 0.45 +/- 0.12. Mean EQ for RCT with insufficient MQ (n = 49) was 0.43 +/- 0.12; Mean EQ for RCT with good MQ (Jadad score > 9)(n = 88) was 0.46 +/- 0.11. There was significant improvement in MQ depending on the year in which the study was started (p = 0.002). EQ was independent of the year of study's start (p = 0.134).There was no relationship between MQ or EQ and the number of patients included in the study (p = 0.53 and p = 0.1). There was a tendency towards correlation between MQ and EQ (p = 0.052), but the correlation between these two variables could not be considered as significant (r = 0.67). Informed consent from patients (ICP) was not obtained in 5.8% (n = 8) of the RCTs and the approval of a research ethics committee (REC) was not mentioned in 26.3% (n = 36) of the RCTs. CONCLUSIONS: Good MQ and reporting of ethical requirements (EQ) reflects the respect shown to the patients during the whole research process. There are still deficiencies in EQ and MQ. Quality improvement requires education and appropriation by the scientific community, in particular, medical staff, of methodological and ethical basic rules concerning trials involving human beings.

Small-bowel adenocarcinoma in patient with Crohn's disease: report of a series of three cases.

Patients affected with Crohn's disease (CD) have a recognized, but low relative risk of developing small-bowel adenocarcinoma (SBA). In fact, SBA develops in 2.2% of patients who have long-standing CD and it is seldom diagnosed preoperatively because of its rarity. A retrospective analysis of all cases of SBA in CD patients since 1980 was carried out in Rouen University Hospital. Three patients with known or unknown CD who presented with SBA with long-term follow-up were analysed. In our first case, the occlusive syndrome revealed SBA and CD simultaneously. Most ileal carcinomas in CD are located in strictures and are often incidentally diagnosed postoperatively, as in our three cases. Digestive surgeons and gastroenterologists must be aware that the diagnosis of SBA in CD is often made fortuitously on histological examination after surgical resection for an occlusive syndrome. Failure to detect SBA in patients with CD results in late diagnosis, with poor survival.

Management of patients with carcinoma of the right colon invading the duodenum or pancreatic head.

BACKGROUND: Only few case series have been published about locally advanced carcinoma of the right colon invading the duodenum or pancreas (CRCDP). We report results of a retrospective study about this rare entity focusing on management and prognosis. METHODS: We reviewed the complete data of patients operated for CRCDP between 1988 and 2005 in four French digestive-surgery departments. RESULTS: Fifteen patients were managed [12 men, 3 women, mean age 63 years (43-86)]. These patients underwent attempted curative en bloc resection including right colectomy: 12 were treated by partial duodenectomy (tumours involving only a part of the duodenum); 3 were treated by pancreaticoduodenectomy. All tumours resected had clear resection margins (R0). About 53% of patients had hepatic metastases, duodenocolic fistula, carcinomatosis, abscess or perforation at presentation. Surgery was performed in emergency in 26% of cases. About 20% of patients had serious postoperative complications (heart failure, bile duct necrosis, septic shock), and three other patients had postoperative anastomotic leaks. No patient experienced duodenal fistula after partial duodenectomy. The mean median survival in resected patients was 22 months (0-122). Overall 1 and 3 years survival were 68% (n=7) and 56% (n=4). Despite clear resection margins in all patients, 26% of patients developed recurrence (duodenal wall resection n=3; pancreaticoduodenectomy n=1). CONCLUSION: Morbidity and mortality after colectomy and en bloc partial duodenectomy or pancreaticoduodenectomy are high but in selected cases could offer prolonged survival. Aggressive surgery including major resection should be performed to obtain clear resection margins even in case of complicated forms.

A new implantation procedure of artificial sphincter for anal incontinence: the transvaginal approach.

A destroyed or severely scarred anterior perineum predicts difficult healing and risk of perineal erosion and remains a contraindication for the implantation of an artificial anal sphincter via a perineal approach. This report describes the first implantations of an artificial anal sphincter via a transvaginal approach in female patients with anal incontinence. Between 2003 and 2005, the Acticon Neosphincter was implanted via a transvaginal approach in nine patients (average age, 43 (range, 25-73) years). These patients had severe fecal incontinence and failed previous therapies or were not amenable to lesser forms of therapy. A successful outcome was achieved in eight of nine patients (89 percent), and for these eight patients the artificial anal sphincter was activated. With a mean follow-up of 21.5 (range, 8-38) months, the mean Cleveland Clinic Score of incontinence decreased from 19 (range, 18-20) before the procedure to 8.6 (range, 2-14) at the last follow-up. None of the patients complained of dyspareunia; vaginal length was not a significant consideration, because this procedure does little to compromise this parameter. This approach is not without complications but its success rate is notable, especially when taking into account that these are patients not amenable to other therapies and only candidates to permanent colostomy.

[Uroflowmetric functional evaluation of modified Duplay procedure in hypospadias surgery]. / Evaluation fonctionnelle par débitmétrie de l'urétroplastie de Duplay modifiée dans la chirurgie de l'hypospade.

We perform a modified Duplay procedure in our department without incision of the urethral plate for correction of distal hypospadias. The objective of this retrospective study was to analyse the long-term functional and aesthetic results of this technique. Strictures are a frequent complication of hypospadias surgery, but their frequency is often underestimated as they can remain asymptomatic. We decided to systematically detect urethral strictures by performing voiding uroflowmetry in all children over the age of 4 years, i.e. toilet trained, operated by Duplay procedure in our department. The results were compared to the standard results in paediatric populations published in the literature. The maximum flow rate was below the 5th percentile in 20% of cases and the average flow rate was abnormal in 30% of cases. Voiding uroflowmetry is a simple, noninvasive method to detect asymptomatic urethral strictures. Uroflowmetry is essential to evaluate the functional results of surgical procedures used for the treatment of hypospadias.