International Journal of Surgery 13 (2015) 142e147
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Study of anorectal function after transanal endoscopic surgery pez a, *, X. Serra Aracil a, J. Hermoso Bosch a, P. Rebasa b, S. Navarro Soto b L. Mora Lo a b
Coloproctology Unit, General and Digestive Surgery, Hospital Univeristari Parc Tauli, Sabadell, Barcelona, Spain Gastroenterology Unit, General and Digestive Surgery, Hospital Univeristari Parc Tauli, Sabadell, Barcelona, Spain
h i g h l i g h t s Anal dilatation produces alteration in the internal anal sphincter with unknown repercussion in faecal continence. Every body thought anal dilatation produces incontinence but anyone have demonstrate this. Anal dilatation Fecal incontinence TEM. No predictors of postoperative incontinencer were observed. TEM is a safe technique and does no affect incontinence.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 6 June 2014 Received in revised form 17 November 2014 Accepted 21 November 2014 Available online 6 December 2014
Aim: To evaluate the impact of Transanal Endoscopic Microsurgery (TEM) on anorectal function, using clinical and manometric assessments. To identify subgroups likely to develop incontinence after TEM, by stratifying the sample. Method: Descriptive, prospective study. Between December 2004 and May 2011, 222 patients were operated on at our hospital, of whom 21 were excluded from the study. Patients underwent anal manometry and answered a clinical incontinence questionnaire (the Wexner scale) prior to surgery, one month post-surgery, and then at four months post-surgery. Results: There were no statistically significant differences between preoperative Wexner questionnaire scores and values at one month and four months post-surgery. Preoperative baseline pressure (BP) values were 64 mmHg ± 26.18, falling to 44.26mmHg ± 20.11 at one month and to 48.86 mmHg ± 21.14 at four months. Voluntary Contraction Pressure (VCP) reached preoperative values of 200.49 mmHg ± 88.85, falling to 169.5 mmHg ± 84.95 and to 173.6 ± 79 at four months. The differences in BP and VCP were statistically significant. The sample was stratified in order to identify subsets susceptible to incontinence after surgery, but no at-risk subgroups were found. Multivariate analysis did not detect any predictors of incontinence. Conclusion: The sustained, controlled anal dilatation produced with TEM caused statistically significant decreases in VCP and BP one month and four months after surgery. However, the Wexner questionnaire scores did not show any association with clinical incontinence. No predictors of postoperative incontinence were observed. We conclude that TEM is a safe technique and does not affect continence. © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Transanal endoscopic surgery Continence
What does this paper add to the literature
1. Introduction
The paper challenges the idea that anal dilatation may produce fecal incontinence. It shows that the sustained, controlled anal dilatation caused by TEM is not associated with incontinence. Therefore, this technique does not increase the risk of incontinence in the immediate postoperative period.
The gold standard in rectal cancer surgery continues to be total mesorectal excision (TME) [1]. However, TME is associated with high morbidity: urinary incontinence, fecal incontinence, sexual dysfunction, and the need for temporary or permanent ostomies in 10e30% of cases [2e5]. The introduction of Transanal Endoscopic Microsurgery (TEM), first described by Buess [6] in 1983, allowed local excision of rectal lesions up to 15e20 cm from the anal verge. Later, Transanal Endoscopic Operation (TEO) was developed [7] which incorporated the technical characteristics of laparoscopy.
* Corresponding author. Coloproctology Unit, Hospital Universitari Parc Tauli, Parc Tauli s/n, 08208 Sabadell, Barcelona, Spain. pez). E-mail address: [email protected] (L. Mora Lo http://dx.doi.org/10.1016/j.ijsu.2014.11.021 1743-9191/© 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
TEO and TEM both provide perfect vision during resection, allowing unfragmented excision of lesions with clear margins and facilitating the maneuvers of dissection, cutting, coagulation and suturing. TEO/TEM are associated with lower morbidity and mortality [8,9] than transabdominal resection techniques, and may also avoid the need for a permanent colostomy. In its early days, TEM made it possible to treat benign lesions and adenocarcinomas in early stages [10]; now, it is accepted in the NCCN guidelines for the treatment of incipient rectal tumors. The equipment used in TEM includes a 4-cm diameter rectoscope which is inserted at the beginning of surgery and is maintained in place until the end of the intervention. The presence of the rectoscope throughout the procedure produces a controlled, sustained anal dilatation which may alter anorectal function and may potentially cause clinical incontinence [11e13]. The main aim of our study was to assess the effects of this technique on anorectal function, assessed by the Wexner scale [14] and by an anorectal manometry study. We also stratified the sample in order to identify subgroups likely to develop incontinence after undergoing TEM. 2. Material and methodmaterials-methods Descriptive, prospective study of 222 patients operated on using TEM at the Parc Taulí University Hospital between December 2004 and May 2009. This study no required an Ethical Approval. Preoperatively, all patients underwent total fibrocolonoscopy with biopsy, endorectal and endoanal ultrasound, pelvic magnetic resonance [14], blood test, simple chest radiography, electrocardiogram and, in the presence of tumor, computed tomography of the abdomen and study of tumor markers. All patients were reviewed by our hospital's multidisciplinary committee for colorectal tumors. 2.1. Selection criteria Inclusion criteria in the study were: benign rectal tumors located up to 20 cm from the anal verge; early stage rectal adenocarcinomas situated up to 20 cm from the anal verge (T1N0). Exclusion criteria: Patient's refusal to enter the study, absolute contraindication for performing manometry, palliative surgery indication, underlying disease impeding manometry or completion of the Wexner questionnaire, need for reoperation with transanal endoscopic surgery, and recurrence of disease during follow-up. 2.2. Examinations Patients who met the inclusion criteria were informed of the nature of the study and gave signed consent before enrollment. Anorectal function was studied preoperatively, and one month and at four months post-surgery by means of the Wexner test and anorectal manometry. We use Wexner scale because is the most widely use. Manometry was performed using a Mul Pump manometer calibrated by trained technical personnel. The gauge was connected to a Polygraf ID amplifier (Medtronics, Minnesota). A single-use 8-channel manometry catheter and another single-use balloon catheter at the distal end were used to study rectal sensitivity, anal reflex, and compliance. All calculations were performed automatically with the Medtronics software. The examination was carried out by two researchers. Basal Pressure (BP) and Voluntary Contraction Pressure (VCP) were measured, taking the highest value recorded as valid. The clinical survey (Wexner questionnaire) was administered during the manometry study by the same researchers.
143
2.3. Surgical technique On the day before TEM, all patients underwent mechanical bowel preparation and thromboembolic prophylaxis. On the day of surgery they received the standard antibiotic prophylaxis for colon surgery at our hospital. Either locoregional or general anesthesia was used, depending on the characteristics of the patient and the lesion. The patient was placed in supine, lateral or prone position, depending on the lesion site. In all cases full-thickness wall excision was performed and the defect sutured [16]. In the postoperative period, our hospital's standard protocol was applied: removal of bladder catheter on leaving the surgical theater, initiation of oral tolerance 6 h after surgery [17], early ambulation and discharge on day 3 in the majority of cases. 2.4. Principal variables The Wexner score, BP and VCP were recorded preoperatively and one month and at four months post-surgery. BP and VCP reflect anal sphincter function: BP reflects internal anal sphincter function, and VCP external. Inhibitory anal reflex and rectal sensitivity values ranged widely and so no accurate analysis could be performed. Secondary variables recorded were age, sex, lesion size, distance from the anal verge, histology of the lesion, surgical time, postoperative complications, hospital stay and mortality. In an attempt to detect any subgroups likely to present postoperative incontinence, the sample was stratified (Table 1). To calculate the number of patients needed to compare two means, since the data were paired we assumed a standard deviation of 25 (based on our previous results), an effect size of 5 mm Hg, a p-value 0.05 and a power of 80%. To meet these conditions, a minimum of 199 patients was needed. The study required paired data because patients were used as their own controls before and after surgery. In the literature there are no reliable data regarding BP and VCP in healthy patients, to give more statistical strength to the data obtained. Table 1 Sample stratification. Patient characteristics Sex Age
Tumor characteristics Distance from anal verge
Tumor size
Quadrant affected
Characteristics of surgical procedure Surgical time
Surgical position
TUMOR TYPE Adenocarcinoma Adenoma Residual scar postpolipectomy Carcinoide Gastrointestinal tumor (GIST)
Male Female 60 years 61e75 years 76 years
10 cm 3 cm 3e5 cm >5 cm Anterior Posterior Lateral
60 min 60e120 min >120 min 1. Lithotomy 2. Prone 3. Lateral decubitus 104 86 5 5 5
144
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
2.5. Statistical analysis The quantitative variables were described as the means and standard deviations when the distribution was normal, and otherwise as medians and interquartile ranges. Categorical variables were described as absolute numbers and percentages. As the groups were paired, the statistical analysis of the quantitative variables comprised a parametric Student T-test for paired data; if a non-parametric test was necessary the Wilcoxon signed-rank test was used. The Wexner score was analyzed as a categorical variable, since scores 6 indicate incontinence and scores < 6 continence. The data were analyzed using McNemar's test of symmetry. A p value 5 cm in diameter, both BP and VCP remained unchanged one month and four months after surgery. In lesions 5 cm in diameter, BP fell one month and four months after surgery. VCP was maintained four months after surgery in lesions 3 cm in diameter, and decreased in the other strata. The Wexner score showed that this decrease did not lead to clinical incontinence. Quadrant affected: BP fell regardless of tumor location (anterior, posterior or lateral). VCP remained unchanged four months post-surgery in lesions located in the anterior face, but fell in the other strata. Again, the Wexner score showed that this reduction in pressure did not lead to clinical incontinence. Operating time: In procedures lasting 60 min VCP remained unchanged, and also in interventions >120 min at four months after surgery. In the other strata both BP and VCP presented decreases, but no clinical incontinence was reflected by the Wexner score. Surgical position: VCP in patients operated on in the prone position, corresponding to lesions located in the anterior face, were unchanged four months after the operation. In the other strata both VCP and BP at one month and four months postsurgery presented reductions, although once more these decreases did not lead to clinical incontinence according to the Wexner score.
3.3. Multivariate analysis Multivariate analysis was performed in order to identify predictors of clinical or manometric incontinence. The only subgroups found to be susceptible to incontinence after TEM were those with preoperative Wexner scores of 6 points or more, indicating that incontinence prior to surgery was a major determinant of incontinence post-surgery. Neither the linear regression nor the logistic regression model detected any predictors of incontinence.(Table 5)
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
145
Table 3 Bivariate analysis, manometry results and continence questionnaire. BP
Preop-1m Preop-4m
VCP
WEXNER
Difference from the mean
SD
p-value
Difference from the mean
SD
p-value
McNemar (Sig)
20.10 mmHg 16.57 mmHg
23.36 24.56
P < 0.001 P < 0.001
22.75 mmHg 21.06 mmHg
56.23 55.69
P < 0.001 P < 0.001
1 0.4
4. Discussion Most studies of TEM in the literature are designed to assess the oncological results obtained with the technique. Few studies have assessed its possible impact on incontinence [18e22]. The first problem we encountered when assessing whether our patients suffered from anorectal incontinence is the definition of the term itself. It is unclear how incontinence should be evaluated since there is no objective test with sufficient specificity and sensitivity to provide correct diagnosis. Several clinical tests are available, but none offer satisfactory reliability. The most widely used test is the Wexner scale [15]. The study by Vaizey [23]
demonstrated this questionnaire's high internal and external validity, although it has certain limitations e for instance, assigning the same value to losses of soft stool, liquid or gas. In the present study, if we had a large number of incontinent patients and if our aim had actually been to establish the clinical impact of this condition on quality of life, perhaps the Wexner test would not have been the ideal choice. On the other hand, as it has been widely used in the literature to assess continence, our results are easier to compare with those of other studies. Of all the tests available for diagnosing incontinence (endoanal ultrasound, nerve stimulation, electromyography, defecography and anal manometry) [24], we chose anal manometry because it is
Table 4 Stratified analysis. BP
SEX FEMALE MALE AGE 60 years
Preop-1m Preop-4m Preop-1m Preop-4m
Preop-1m Preop-4m 61e75 years Preop-1m Preop-4m 76 years Preop-1m Preop-4m DISTANCE FROM ANAL VERGE 5 cm Preop-1m Preop-4m 5e10 cm Preop-1m Preop-4m 10 cm (N < 30) Preop-1m Preop-4m LESION SIZE 3 cm Preop-1m Preop-4m 3e5 cm Preop-1m Preop-4m >5 cm (N < 30) Preop-1m Preop-4m LESION LOCATION Anterior Preop-1m Preop-4m Posterior Preop-1m Preop-4m Lateral Preop-1m Preop-4m SURGICAL TIME 60 min (N < 30) Preop-1m Preop-4m 60e120 min. Preop-1m Preop-4m >120 min (N < 30) Preop-1m Preop-4m SURGICAL POSITION Lithotomy Preop-1m Preop-4m Prone Preop-1m Preop-4m Lateral decubitus Preop-1m Preop-4m
VCP
Difference from the mean (mm Hg) (SD)
Sig
18.68 18.87 21.03 15.24
(24.34) (24.66) (22.8) (24.5)
p p p p
< < <
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Study of anorectal function after transanal endoscopic surgery pez a, *, X. Serra Aracil a, J. Hermoso Bosch a, P. Rebasa b, S. Navarro Soto b L. Mora Lo a b
Coloproctology Unit, General and Digestive Surgery, Hospital Univeristari Parc Tauli, Sabadell, Barcelona, Spain Gastroenterology Unit, General and Digestive Surgery, Hospital Univeristari Parc Tauli, Sabadell, Barcelona, Spain
h i g h l i g h t s Anal dilatation produces alteration in the internal anal sphincter with unknown repercussion in faecal continence. Every body thought anal dilatation produces incontinence but anyone have demonstrate this. Anal dilatation Fecal incontinence TEM. No predictors of postoperative incontinencer were observed. TEM is a safe technique and does no affect incontinence.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 6 June 2014 Received in revised form 17 November 2014 Accepted 21 November 2014 Available online 6 December 2014
Aim: To evaluate the impact of Transanal Endoscopic Microsurgery (TEM) on anorectal function, using clinical and manometric assessments. To identify subgroups likely to develop incontinence after TEM, by stratifying the sample. Method: Descriptive, prospective study. Between December 2004 and May 2011, 222 patients were operated on at our hospital, of whom 21 were excluded from the study. Patients underwent anal manometry and answered a clinical incontinence questionnaire (the Wexner scale) prior to surgery, one month post-surgery, and then at four months post-surgery. Results: There were no statistically significant differences between preoperative Wexner questionnaire scores and values at one month and four months post-surgery. Preoperative baseline pressure (BP) values were 64 mmHg ± 26.18, falling to 44.26mmHg ± 20.11 at one month and to 48.86 mmHg ± 21.14 at four months. Voluntary Contraction Pressure (VCP) reached preoperative values of 200.49 mmHg ± 88.85, falling to 169.5 mmHg ± 84.95 and to 173.6 ± 79 at four months. The differences in BP and VCP were statistically significant. The sample was stratified in order to identify subsets susceptible to incontinence after surgery, but no at-risk subgroups were found. Multivariate analysis did not detect any predictors of incontinence. Conclusion: The sustained, controlled anal dilatation produced with TEM caused statistically significant decreases in VCP and BP one month and four months after surgery. However, the Wexner questionnaire scores did not show any association with clinical incontinence. No predictors of postoperative incontinence were observed. We conclude that TEM is a safe technique and does not affect continence. © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Transanal endoscopic surgery Continence
What does this paper add to the literature
1. Introduction
The paper challenges the idea that anal dilatation may produce fecal incontinence. It shows that the sustained, controlled anal dilatation caused by TEM is not associated with incontinence. Therefore, this technique does not increase the risk of incontinence in the immediate postoperative period.
The gold standard in rectal cancer surgery continues to be total mesorectal excision (TME) [1]. However, TME is associated with high morbidity: urinary incontinence, fecal incontinence, sexual dysfunction, and the need for temporary or permanent ostomies in 10e30% of cases [2e5]. The introduction of Transanal Endoscopic Microsurgery (TEM), first described by Buess [6] in 1983, allowed local excision of rectal lesions up to 15e20 cm from the anal verge. Later, Transanal Endoscopic Operation (TEO) was developed [7] which incorporated the technical characteristics of laparoscopy.
* Corresponding author. Coloproctology Unit, Hospital Universitari Parc Tauli, Parc Tauli s/n, 08208 Sabadell, Barcelona, Spain. pez). E-mail address: [email protected] (L. Mora Lo http://dx.doi.org/10.1016/j.ijsu.2014.11.021 1743-9191/© 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
TEO and TEM both provide perfect vision during resection, allowing unfragmented excision of lesions with clear margins and facilitating the maneuvers of dissection, cutting, coagulation and suturing. TEO/TEM are associated with lower morbidity and mortality [8,9] than transabdominal resection techniques, and may also avoid the need for a permanent colostomy. In its early days, TEM made it possible to treat benign lesions and adenocarcinomas in early stages [10]; now, it is accepted in the NCCN guidelines for the treatment of incipient rectal tumors. The equipment used in TEM includes a 4-cm diameter rectoscope which is inserted at the beginning of surgery and is maintained in place until the end of the intervention. The presence of the rectoscope throughout the procedure produces a controlled, sustained anal dilatation which may alter anorectal function and may potentially cause clinical incontinence [11e13]. The main aim of our study was to assess the effects of this technique on anorectal function, assessed by the Wexner scale [14] and by an anorectal manometry study. We also stratified the sample in order to identify subgroups likely to develop incontinence after undergoing TEM. 2. Material and methodmaterials-methods Descriptive, prospective study of 222 patients operated on using TEM at the Parc Taulí University Hospital between December 2004 and May 2009. This study no required an Ethical Approval. Preoperatively, all patients underwent total fibrocolonoscopy with biopsy, endorectal and endoanal ultrasound, pelvic magnetic resonance [14], blood test, simple chest radiography, electrocardiogram and, in the presence of tumor, computed tomography of the abdomen and study of tumor markers. All patients were reviewed by our hospital's multidisciplinary committee for colorectal tumors. 2.1. Selection criteria Inclusion criteria in the study were: benign rectal tumors located up to 20 cm from the anal verge; early stage rectal adenocarcinomas situated up to 20 cm from the anal verge (T1N0). Exclusion criteria: Patient's refusal to enter the study, absolute contraindication for performing manometry, palliative surgery indication, underlying disease impeding manometry or completion of the Wexner questionnaire, need for reoperation with transanal endoscopic surgery, and recurrence of disease during follow-up. 2.2. Examinations Patients who met the inclusion criteria were informed of the nature of the study and gave signed consent before enrollment. Anorectal function was studied preoperatively, and one month and at four months post-surgery by means of the Wexner test and anorectal manometry. We use Wexner scale because is the most widely use. Manometry was performed using a Mul Pump manometer calibrated by trained technical personnel. The gauge was connected to a Polygraf ID amplifier (Medtronics, Minnesota). A single-use 8-channel manometry catheter and another single-use balloon catheter at the distal end were used to study rectal sensitivity, anal reflex, and compliance. All calculations were performed automatically with the Medtronics software. The examination was carried out by two researchers. Basal Pressure (BP) and Voluntary Contraction Pressure (VCP) were measured, taking the highest value recorded as valid. The clinical survey (Wexner questionnaire) was administered during the manometry study by the same researchers.
143
2.3. Surgical technique On the day before TEM, all patients underwent mechanical bowel preparation and thromboembolic prophylaxis. On the day of surgery they received the standard antibiotic prophylaxis for colon surgery at our hospital. Either locoregional or general anesthesia was used, depending on the characteristics of the patient and the lesion. The patient was placed in supine, lateral or prone position, depending on the lesion site. In all cases full-thickness wall excision was performed and the defect sutured [16]. In the postoperative period, our hospital's standard protocol was applied: removal of bladder catheter on leaving the surgical theater, initiation of oral tolerance 6 h after surgery [17], early ambulation and discharge on day 3 in the majority of cases. 2.4. Principal variables The Wexner score, BP and VCP were recorded preoperatively and one month and at four months post-surgery. BP and VCP reflect anal sphincter function: BP reflects internal anal sphincter function, and VCP external. Inhibitory anal reflex and rectal sensitivity values ranged widely and so no accurate analysis could be performed. Secondary variables recorded were age, sex, lesion size, distance from the anal verge, histology of the lesion, surgical time, postoperative complications, hospital stay and mortality. In an attempt to detect any subgroups likely to present postoperative incontinence, the sample was stratified (Table 1). To calculate the number of patients needed to compare two means, since the data were paired we assumed a standard deviation of 25 (based on our previous results), an effect size of 5 mm Hg, a p-value 0.05 and a power of 80%. To meet these conditions, a minimum of 199 patients was needed. The study required paired data because patients were used as their own controls before and after surgery. In the literature there are no reliable data regarding BP and VCP in healthy patients, to give more statistical strength to the data obtained. Table 1 Sample stratification. Patient characteristics Sex Age
Tumor characteristics Distance from anal verge
Tumor size
Quadrant affected
Characteristics of surgical procedure Surgical time
Surgical position
TUMOR TYPE Adenocarcinoma Adenoma Residual scar postpolipectomy Carcinoide Gastrointestinal tumor (GIST)
Male Female 60 years 61e75 years 76 years
10 cm 3 cm 3e5 cm >5 cm Anterior Posterior Lateral
60 min 60e120 min >120 min 1. Lithotomy 2. Prone 3. Lateral decubitus 104 86 5 5 5
144
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
2.5. Statistical analysis The quantitative variables were described as the means and standard deviations when the distribution was normal, and otherwise as medians and interquartile ranges. Categorical variables were described as absolute numbers and percentages. As the groups were paired, the statistical analysis of the quantitative variables comprised a parametric Student T-test for paired data; if a non-parametric test was necessary the Wilcoxon signed-rank test was used. The Wexner score was analyzed as a categorical variable, since scores 6 indicate incontinence and scores < 6 continence. The data were analyzed using McNemar's test of symmetry. A p value 5 cm in diameter, both BP and VCP remained unchanged one month and four months after surgery. In lesions 5 cm in diameter, BP fell one month and four months after surgery. VCP was maintained four months after surgery in lesions 3 cm in diameter, and decreased in the other strata. The Wexner score showed that this decrease did not lead to clinical incontinence. Quadrant affected: BP fell regardless of tumor location (anterior, posterior or lateral). VCP remained unchanged four months post-surgery in lesions located in the anterior face, but fell in the other strata. Again, the Wexner score showed that this reduction in pressure did not lead to clinical incontinence. Operating time: In procedures lasting 60 min VCP remained unchanged, and also in interventions >120 min at four months after surgery. In the other strata both BP and VCP presented decreases, but no clinical incontinence was reflected by the Wexner score. Surgical position: VCP in patients operated on in the prone position, corresponding to lesions located in the anterior face, were unchanged four months after the operation. In the other strata both VCP and BP at one month and four months postsurgery presented reductions, although once more these decreases did not lead to clinical incontinence according to the Wexner score.
3.3. Multivariate analysis Multivariate analysis was performed in order to identify predictors of clinical or manometric incontinence. The only subgroups found to be susceptible to incontinence after TEM were those with preoperative Wexner scores of 6 points or more, indicating that incontinence prior to surgery was a major determinant of incontinence post-surgery. Neither the linear regression nor the logistic regression model detected any predictors of incontinence.(Table 5)
pez et al. / International Journal of Surgery 13 (2015) 142e147 L. Mora Lo
145
Table 3 Bivariate analysis, manometry results and continence questionnaire. BP
Preop-1m Preop-4m
VCP
WEXNER
Difference from the mean
SD
p-value
Difference from the mean
SD
p-value
McNemar (Sig)
20.10 mmHg 16.57 mmHg
23.36 24.56
P < 0.001 P < 0.001
22.75 mmHg 21.06 mmHg
56.23 55.69
P < 0.001 P < 0.001
1 0.4
4. Discussion Most studies of TEM in the literature are designed to assess the oncological results obtained with the technique. Few studies have assessed its possible impact on incontinence [18e22]. The first problem we encountered when assessing whether our patients suffered from anorectal incontinence is the definition of the term itself. It is unclear how incontinence should be evaluated since there is no objective test with sufficient specificity and sensitivity to provide correct diagnosis. Several clinical tests are available, but none offer satisfactory reliability. The most widely used test is the Wexner scale [15]. The study by Vaizey [23]
demonstrated this questionnaire's high internal and external validity, although it has certain limitations e for instance, assigning the same value to losses of soft stool, liquid or gas. In the present study, if we had a large number of incontinent patients and if our aim had actually been to establish the clinical impact of this condition on quality of life, perhaps the Wexner test would not have been the ideal choice. On the other hand, as it has been widely used in the literature to assess continence, our results are easier to compare with those of other studies. Of all the tests available for diagnosing incontinence (endoanal ultrasound, nerve stimulation, electromyography, defecography and anal manometry) [24], we chose anal manometry because it is
Table 4 Stratified analysis. BP
SEX FEMALE MALE AGE 60 years
Preop-1m Preop-4m Preop-1m Preop-4m
Preop-1m Preop-4m 61e75 years Preop-1m Preop-4m 76 years Preop-1m Preop-4m DISTANCE FROM ANAL VERGE 5 cm Preop-1m Preop-4m 5e10 cm Preop-1m Preop-4m 10 cm (N < 30) Preop-1m Preop-4m LESION SIZE 3 cm Preop-1m Preop-4m 3e5 cm Preop-1m Preop-4m >5 cm (N < 30) Preop-1m Preop-4m LESION LOCATION Anterior Preop-1m Preop-4m Posterior Preop-1m Preop-4m Lateral Preop-1m Preop-4m SURGICAL TIME 60 min (N < 30) Preop-1m Preop-4m 60e120 min. Preop-1m Preop-4m >120 min (N < 30) Preop-1m Preop-4m SURGICAL POSITION Lithotomy Preop-1m Preop-4m Prone Preop-1m Preop-4m Lateral decubitus Preop-1m Preop-4m
VCP
Difference from the mean (mm Hg) (SD)
Sig
18.68 18.87 21.03 15.24
(24.34) (24.66) (22.8) (24.5)
p p p p
< < <
