Evaluation of sphincter-preserving surgery for rectal cancer

Evaluation  of sphincter-preserving surgery for rectal cancer

Ahmed Gaber Mahmoud,MDI; Ayman M.A.Ali,MDI; Wael Barakaat Ahmed,MSI; Ahmed R.H. Ahmed, Ph.D., MD2; Abd El-Hafez Hosny,MDI

1) General Surgery Department, Sohag University, Egypt.

2) Pathology Department, Sohag University, Egypt.

Background: Rectal carcinoma constitutes a health problem, previously managed with abdomino-perineal  resection (APR) which has the impact of poor patient quality of life. With the introduction of the concept of total mesorectal excision (TME) and stapler technology, sphincter  saving surgery (SSS)  with its better local control and functional  status is a better choice than APR. We tried to evaluate the operative safety, long-term oncologic andfunctional outcomes of SSS in rectal carcinoma.

Patients  and methods:  Between  October  2008  and October  2012,  patients  with  rectal

carcinoma who presented electively to Sohag University Hospital underwent SSSbased on sharp mesorectal excision in the form of anterior resection, low anterior resection and intersphincteric resection were evaluated. Patients were followed up for four years.

Results: A total of 60 patients underwent SSS, regarding operative  complications;  there

were 2 ureteric injuries and one bladder injury. Postoperatively, anastomotic leakage occurred in 6.7% of cases.  Local recurrence and distant metastases were detected in 8.3% 13.3% respectively. During follow-up, disease-free survival rate was 66.9%, overall survival rate was

93%, 22% of patients had a degree ofincontinence. 21.66% had temporary bladder dysfunction. Sexual dysfunction became evident in 30% of male patients.

Conclusion: SSS with TME provides a better alternative to APR in rectal carcinoma when

feasible.

Key words: Sphincter saving surgery, total mesorectal excision, stapler.

Introduction:

Rectal cancer constitutes 5% of malignant tumors, and ranks as the fifth most common cancer in adults.l It is curable when localized to the bowel, radical resection makes cure in

50% of cases.2

Preservation  of  anal  sphincter,  bladder, and sexual function with maintenance or improvement  in quality  of life besides local control and long-term survival  are the main goals while managing rectal carcinoma.3

APR  is  now  considered  unnecessary  in most patients with rectal cancer and more patients  can be treated  with SSS due to the increased understanding of the spread of the disease.  Distal  mural  spread  of the  disease was  shown  to  be  rarely  more  than  2 em,4

this allowed the increased  use of SSS. Also the advances of mechanical stapling devices and the development of the double stapling technique made anastomoses at the distal rectum or the anal canal possible and safe.5

The recognition of  TME for colorectal cancer  surgery  [with  careful  dissection  of the avascular plane between the mesorectum and parietal fascia, the envelope of the mesorectum    (which    encompasses    tumor cells)   is   kept   intact,   thereby   preventing the dissemination of cancerous cells] is of significant importance.6   TME has improved the    local  control  with/  or  without  the  use of neo-adjuvant radiotherapy,  with reduced recurrence  rate from 30% down to less than

10% thus improving the overall survival.7,8

Most patients have tumors confined to the rectum and mesorectum and may be cured by TME based surgery.9 However, 10-15% of patients have locally more advanced tumors, i.e. tumors which are fixed to adjacent structures within the pelvislO and those with a local recurrence, multidisciplinary treatment strategies are needed.9

Sphincter saving procedures can be performed to all patients with rectal carcinoma regardless of the site of the lesion so long the distal and lateral margins are clear. 11

Aim of the work:

The purpose of this study was to evaluate the outcome of SSS in management of rectal carcmoma.

Patients and methods:

This study was conducted prospectively over patients who had non-fixed rectal carcinoma and presented electively from October 2008 to October 2012, at Sohag University Hospital, admitted through the outpatient clinic.

Patients were included in the study if they

had a well functioning anal sphincters and the tumor was as low as 2 em above the dentate line.

Patients were excluded if their tumors infiltrated  the  anal  sphincter,  women requiring posterior vaginectomy for adequate tumor clearance, those who received adjuvant therapy for a previous pelvic cancer, and resection for recurrent disease.

All patients had medical  history, clinical

examination, digital examination, endorectal ultrasonography   and  colonoscopy  with biopsy. Tumors were divided  into; low, middle, or high rectal tumors if their lowest edge were 0 to 5 em, 5.1 to 10 em, and 10.1 em to 15 em from the anal verge respectively.

All  patients  underwent  abdomina-pelvic

computed tomography (CT), magnetic resonance    imaging    and    cystoscopy    m patients with urinary symptoms. Laboratory investigations included serum carcino­ embryonic  antigen  (CEA)  and routine  tests for physical fitness. All patients underwent routine mechanical and chemical preparation.

Data  collected  were  patients' demographics, co-morbidities, operative details, operative morbidity and mortality, histological results, short and long-term outcomes.

Surgical techniques:

Surgical management was performed by SSS  including  anterior  resection  for  high­ rectal tumors, low anterior resection for mid­ rectal tumors and inter-sphincteric  resection for low-rectal tumors. All patients underwent resection  using  a  sharp  perimesorectal excision technique.12 In all cases a trial was paid to preserve the pelvic autonomic nerve trunks medial to the parietal fascia.l3

Restoration   of   gut   continuity   after   a

thorough irrigation of the pelvic cavity and irrigation of the rectal stump with povidone iodine was accomplished by double-stapling; transverse stapler, circular stapler of the appropriate  size  (Ethicon  Endosurgery® USA), or hand sewn colorectal anastomosis.

A transanal  coloanal anastomosis was performed    when    the    transverse    stapler could not be applied with adequate margin below the tumor. After full abdominal mobilization  of the rectum, the surgeon completed the excision transanally at the dentate line. A hand sewn interrupted single layer anastomosis  was performed  at the dentate   line.  Our   distal  resection   margin (DRM) was 1 em for T1-2 lesions and 2 em for T3-4 tumors.l4 Intersphincteric resection (ISR) was performed in a low rectal cancer (tumor located <2 em from the anal ring, T1-

2, not infiltrating the external anal sphincter and with favorable pathology) after pelvic dissection from the abdominal approach with division of the full thickness of the internal sphincter  transanally,  1 to 2 em distal from the tumor, or removal of the upper one-half of the internal anal sphincter for tumors located between  3  and  5  em  from  the  anal  verge (partial ISR). A diversion stoma was created in case of technical difficulty, a positive leakage test, incomplete doughnuts, or a very low anastomosis within 3 em from the anal verge.

The    resected     tumors     were     evaluated

macroscopically  for  tumor  site,  size,  depth of invasion and distance from proximal and distal surgical resection margins. The peri­ rectal lymph nodes were carefully dissected counted and sampled for assessment of metastasis.  The histological  tumor  type, grade,  depth  of  invasion  (T-stage),  lymph node deposits (N-stage) were evaluated microscopically.

Patients were followed up every 3 months

during the first 2 years and then every 6 months for the further two years, average follow-up 20 months. Follow-up included history, physical examination, and serum CEA. Digital rectal examination was performed to detect any anastomotic   stricture   or  local   recurrence. If recurrence was suspected, endoscopic examination  and  CT  scan  were  performed to determine whether  salvage surgery could be performed. Continence was assessed by Kirwan-Fazio classification,l5 patients with stoma were assessed after stoma closure.

Adjuvant     radiation     therapy     was     not

routinely  given to  patients  with stage  II or stage III. Postoperative chemo-radiation was given when there is doubt of local clearance. Chemotherapy based on 5-fiuorouracil was prescribed to patients younger than 75 years with TNM stage II or stage III disease.

Statistical analysis:

The commercially available statistical software (IBM-SPSS verswn  19.0 for Windows; IBM Inc) was used for  data analysis. The frequencies  of a categorical observation among different groups was compared by Chi-Square Test and Fisher's Exact Test and the correlation between categorical variables and other continuous variables   was   by   Spearman's    rho   Test. Kaplan Meier Survival analysis was used to calculate the recurrence  rate and to estimate the Log-Rank among different groups. The association of different clinical and operative factors  and risk of recurrence of the disease was evaluated by Binary Logistic regression analysis.  The cut-off for  significance  of all used statistical analyses was rated asP <0.05.

Results:

This is a descriptive single arm prospective study which included 60 patients with rectal carcinoma,  confirmed by  histopathologic study as adenocarcinoma, who fulfilled the inclusion criteria. Ofthem 40 patients (66.7%) were females and 20 patients (33.3%) were males.  Their  age  ranged  between  16 to  72 years with a mean of (43.82± 15.43) and a median of 43.5 years. In our study; 9 patients (15%) had high rectal tumor, 47 patients (78.3%) had mid-rectal tumor and 4 patients (6.7%) had low-rectal tumor. Operative time ranged  between  90  and  240  minutes.  The mean was (152±35) and the median was 150 minutes.

The anastomosis was completed by stapler

using   a  double   stapling   technique   in  39 patients (65%); all of them were mid-rectal cancer. Hand sewn anastomosis  was used in

21 patients (35%) of whom four (6.6%) were

low and eight (13.33%) were middle and nine (15%) were high rectal tumors. Thirty-seven patients (61.7%) had no diverting stoma, four patients (6.7%) had loop ileostomy and 19 (31.7%) had protective transverse colostomy.

Operative complications were managed intra-operatively and postoperative complications were managed conservatively and responded  well, both were summarized in Table (1).

The factors which may be responsible for

the occurrence of fecal fistula were analyzed; small DRM was significantly associated with fecal  fistula  (Pearson  Chi  Square  =  14.08, P <0.01).  None  of  the  tumor  site,  method of anastomosis, type of the covering stoma, tumor grade or tumor stage had a significant relationship  to  fecal  fistula  (P=0.32,  =0.65

=112, and = 0.727 respectively).   Also there was  no  correlation  between  operative  time and fecal fistula (Spearman·s  rho correlation coefficient, P = 0.161).

Histopathologic  evaluation  revealed  that

24  patients  (40%)  had  well  differentiated adenocarcinoma,   34  patients  (56.7%)   had moderately    differentiated    adenocarcinoma and      two       patients             (3.3%) had          poorly differentiated  adenocarcinoma.  DRM varied according to the site of the tumor, it ranged

from 1-5 em. It was 1 em in seven cases, 2 em in twenty-nine cases, 3 em in nine cases, 4 em in five cases and 5 em in ten cases, resected specimens were examined histopathologically and were free. TNM staging of the tumors based on histopathologic examination of resected  specimens  (for T and N), revealed that T1, T2, T3 and T4 were represented in 4 (6.7%), 26 (43.3%), 29 (48.3%) and 1 (1.7%) cases,   respectively.   Eighteen  cases  (30%) had no lymph nodal deposits (NO), 29 cases (48.3%) had N1 nodal stage and 13 cases (21.7%) had N2 nodal stage. None of the patients  had  distant  metastasis  (MO). There was not any operative mortality.

During     follow-up     there      was      local

recurrence  in five  cases  (8.3%),  4 patients were mid-rectal carcinoma and 1 was low­ rectal carcinoma.  Both tumor site and method of anastomosis had no significant relationship to the local recurrence. Contrary to site of the tumor  and  type  of  anastomosis,  there  was an  inverse  significant  relationship  between the DRM and local recurrence. Regarding tumor grade; high grade tumors tend to have more local recurrence in comparison to low grade tumors, but this relationship does not reach the significance level. Although the relation ofT stage of the primary tumor was insignificant,  local  recurrence  of the  tumor was   significantly   associated   with   higher nodal stage Table (2).

Multivariate statistical analysis was made for factors which could be related to local recurrence.   These  factors   included   tumor site, tumor  grade, T stage,  N stage, type of operation,   method   of  anastomosis,   DRM in addition to operative time. There was no single independent variable correlated with local recurrence based on Binary Logistic Regression Multivariate analysis as shown in Table (3).

Distant   metastasis   happened    in   eight

patients (13.3%) of whom 5 cases had liver deposits, 2 cases had lung deposits and 1 case had multi-organ metastasis.

Disease free survival by Kaplan Meier test

was 66.9% during the study period and the overall survival rate by Kaplan Meier test was

93% Figure (1,2). There were two deaths; 1

due to multiple metastases and the other due to pulmonary metastasis.

We evaluated the relation of different disease  findings  to  continence  status.  The tumor site had a significant impact; low-rectal tumors had a highly significant increased risk of incontinence. Type of anastomosis had a direct effect, according to our results stapler completed anastomosis significantly had less risk of incontinence compared to hand sewn anastomosis. Additionally smaller DRM was more likely to be associated with disturbed postoperative  anal  sphincteric  function.   In the same respect, T stage  of the tumors and overall stage had no correlation Table (4,5).

There were temporary bladder dysfunction

(<3  months)   in  association   with  SSS   in

13 patients (21.7%) and were managed conservatively  by Foley's catheter and one patient  had  permanent  bladder  dysfunction (>3 months) which proved to be neurogenic bladder. In the respect of sexual function,  of

20 male patients who had rectal resection, 6 patients (30%) had sexual  dysfunction,  2 of them had erection problems and the other 4 had ejaculation problems.

Discussion:

The ideal treatment of rectal cancer should preserve the anal sphincter with low morbidity and mortality and favorable oncologic outcomes. Following the introduction ofTME by  Heald  and  the  development  of  staplers, SSS became a better alternative to APR.l6 In the last years, anterior resection with TME excision has become the optimal treatment of rectal cancer.

Still the tumor level is an important factor for the type of the adopted surgery, a DRM of

2 em is sufficient for a SSS which wouldn't affect the survival or local recurrence in patients  with  rectal  cancers.l 7  In  the   last few years there is a developing trend to decrease  the  DRM to 1 em, as it proved to have appropriate clearance for most rectal cancers.l8   In  the   current   study,  a   distal margin clearance with a 2 em DRM for stage I or stage II tumors  was performed  and we did not find any tumor beyond this margin histopathologically.  Our  operative time  was

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Figure (2): Overall survival.

Table 1: Operative and postoperative complications.

Table 2: Factors affecting  local recurrence.

* Factors with bold letters were significant.

* Values in parentheses are percentages.

Table 3: Multivariate analysis for risk factor of local recurrence.

Table 4: The relation of different disease.findings to the continence status.

*No= number.

* Factors with bold letters were significant.

in accordance  with other reports, 19 although       mesorectum but the use of stapler completed it  was  expected   that  time  would  become                                                                                anastomosis saved much time.

was anastomotic leak which was reported previously  to  vary  between  11 and  18%.20

Our rate was 6.7% which was described by others;  2-9  %.21 The  only  factor  found  to be significantly associated with fecal fistula was the smaller  distal resection margin, this mandates  protective colostomy  or ileostomy in such cases.

Before introduction of the modem surgical modalities for treatment of rectal carcinoma, the achievement  of radicality with APR was in expense ofthe patients' quality of life with a  considerable  recurrence  rate of 30%.7,8 In our study, SSS with TME, local recurrence happened in 8.3% which is comparable to others.22 Some may consider this recurrence rate as being low and attribute this to a claimed short  term  follow-up   (mean  = 20  months) which reached 4 years especially that our patients did not receive neoadjuvant therapy, it is known that 80% of the local recurrences occur within the first 2 years after surgery and with neoadjuvant therapy the local recurrence rate reached 1.5%.23

Factors that are possibly associated with local  recurrence  were  analyzed,  of  which DRM was found to have a significant inverse relationship   with   local   recurrence,   tumor with shorter surgical distal margin has been found to have a significant higher potential of local recurrence. Also local recurrence was significantly   associated   with  higher  nodal stage of rectal adenocarcinoma.

The  cancer  free  survival  doesn't   differ

between   SSS   and  APR;18   we  reported  a cancer-specific survival of 66.9%, which is comparable with others' results.24

Our  final  continence   results  after   SSS were   accepted   by  most   of  our   patients. Seventy   eight   percent   of   the   cases  had perfect     postoperative     bowel     functions.

None of the patients had occasional major soiling  or incontinence  requiring colostomy. All    anastomoses    were    end-to-end    and it   is  well   established   that   direct   end-to­ end anastomosis of proximal colon to the anorectal junction results in poorer functional results  in the earlier  postoperative  period,25 so our results are generally satisfactory. Although some encourage pouch formation, most studies showed that pouch and straight coloanal anastomosis function becomes comparable  after  1-2 years.26 According  to our results low rectal tumors had a highly significant   increased   risk  of  incontinence,

2  cases  (66.7%)   with  minor  soiling  were

low rectal cancer as all of these cases (low­ rectal cancer) were managed by hand sewn anastomosis transanally in which there was removal  of  part  of  the   internal  sphincter during ISR, accordingly an element of anal­ sphincter insufficiency occurred  leading to a degree of incontinence.27 The partial loss of sphincter control disappeared spontaneously, as in most reported studies.28

Postoperative good quality of life as a requirement  of the surgical outcome doesn't entail   the   avoidance   of   colostomy   only, but also the avoidance of the postoperative functional disorders of the bladder and sexual organs.  Although sphincter saving operations have problems of frequent bowel movement, urgency, flatulence, and need for frequent medication but they are superior to APR regarding quality of life.29

Earlier    evaluations    have    shown    that after  extensive  conventional  resection, bladder dysfunction due to neurological complications   has  been  reported  in  up  to

54%  of  patients  after  surgical  resection  of

the  rectum.30  In  contrast,  the  introduction of TME was followed  by a reduction  in the

neurological complication rates to  less than

5.3%.29 In this study  21.66% had temporary bladder  dysfunction (<3 months) and were managed conservatively by Foley's catheter. Rectal resection was associated  with sexual dysfunction in  up  to  59%  of  patients.l3 In our study 30% of our male patients who had rectal resection, suffered  sexual  dysfunction.

Conclusion :

SSS should  be considered in patients with a good functioning anal sphincter mechanism and the tumor is more than 2 em above the dentate line. It neither compromises operative safety nor oncologic outcomes.

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