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Medium term results of STARR

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26/12/2011

Medium term results of STARR (Stapled Trans Anal Rectal Resection) for obstructed defecation & symptomatic rectal-anal intussusception.

 Abstract

Introduction:  Although still controversial in the UK and USA, STARR (stapled transanal rectal resection) is an increasingly accepted treatment for obstructed defaecation syndrome (ODS) associated with internal rectal prolapse (IRP) and rectocoele.

Results:  344 patients, median age 54 (19-90), 68% female, underwent STARR over a 9 year period.  Pre-operative symptoms included: pelvic pain (93%), incomplete emptying (90%), faecal urgency (74%), sensation of obstruction (65%) and rectal digitation (27%).  13 had solitary rectal ulcer syndrome (SRUS).  Of 326 patients with follow-up data, 249 were followed-up beyond 1 year, and 149 beyond 2 years (43%), median 98 weeks (CI 85–112).  ODS scores improved (p<0.0001 Wilcoxon Signed Ranks test; 14.6 ± 5.4 pre vs 1.6 ± 3.1 post) as did Faecal Incontinence (FI) scores (p<0.0001 Wilcoxon Signed Ranks test).  15 patients (4.3%) reported deterioration in FI; 11 (3.2%) new-onset.  Urgency was reported in 72% at 8 weeks, 20% at 16 weeks, 11.5% at 52 weeks and 5% at 1.5 years.  Of 29 patients followed-up beyond 4 years, none reported continuing urgency.  Post-operative urgency was unrelated to sex, age, pre-operative ODS symptoms including urgency, FI, previous surgery and SRUS (Mantel-Cox Log Rank).  4.9% developed recurrent symptoms of ODS.  81% were highly satisfied with and would recommend STARR or have it again; a further 9% would probably undergo the procedure again.

Conclusions:  STARR has proved a successful treatment option for selected patients with ODS and IRP.  Postoperative faecal urgency affects 70% of patients but rapidly decays with time; we cannot predict who will be affected.

 

Introduction

Antonio Longo [1] first proposed stapled transanal rectal resection (STARR) as a treatment for obstructed defaecation syndrome (ODS) associated with internal rectal prolapse (IRP) and rectocoele.  Shortly afterwards, a multicentre Italian study [2] of 90 patients, all of who had previously tried and failed a course of biofeedback training (BFT), was published.  The reported outcome measures demonstrated a significant improvement in ODS scores after STARR.  Complications included faecal urgency (17.8%), and incontinence to flatus (8.9%) and stool (3.3%); no serious morbidity or mortality occurred.  Faecal urgency reduced over time.  The mean follow-up was 16 months, at which point patient satisfaction was reported as good or excellent in 90%.  There followed a number of case series [3-7], which apart from one [8] included small numbers of patients and with limited follow-up. All reported good outcomes in approximately 90%.

The European STARR Registry (2006-08) [9] recruited almost 3000 patients.  Although the majority (77%) were Italian, the results showed the same trends across the three countries involved: significant reductions in ODS and symptom severity scores coupled with improved quality of life (PAQ-QoL and EQ-5D) scores.  As with other studies [8] continence improved.  Complications were reported in 36%: pain (7.1%), retention of urine (6.9%), bleeding (5%), sepsis (4.4%) and staple line complications (3.5%).  Post-operative urgency was recorded in 27% of patients at 12 months with faecal incontinence (FI) in 1.8%.  The final report with 12-month follow-up data was published in 2009 and concluded that in the short-term, STARR was safe and effective with significant improvements in ODS and quality of life [9].

Few researchers have compared STARR with other surgical treatments [10].  One randomised controlled trial of 119 patients compared STARR (59 patients) with BFT [11].  Surprisingly, 50% of patients in the BFT arm failed to complete their course of treatment.  As one would predict from a surgical intervention, STARR led to some minor morbidity (15%).  Significant improvements in ODS scores were observed in both groups.  However, the patient-reported satisfaction was considerably higher following STARR (81.5%) than BFT (33%).

What most studies on STARR to date have in common are the relative shortness of their follow-up periods and the under-reported rates of early faecal urgency.  Many studies demonstrate a lack of appreciation as to how faecal urgency decays over time.  In addition, patient follow-up has been insufficient to determine the rate of ODS recurrence; Arroyo et al [12] reported 11 (10.6%) recurrences at 26 weeks and Gagliardi [6] reported 9 (11%) at 17 months.

The aim of this study was to report our up-to-date experience of STARR in 344 patients with particular reference to post-operative faecal urgency and its improvement with time, maintenance of symptom-control and patient satisfaction.

 

Patients and methods

Patients were selected for the STARR procedure after thorough assessment of pelvic floor pathology and function.  Clinical assessment comprised a thorough history and clinical pelvic floor examination of all three compartments.  Dynamic defaecating proctography-vaginography was performed to exclude more proximal intussusception or a co-existing enterocoele and/or sigmoidocoele.  Clinical assessment and examination under general anaesthetic (EUA) are considered the gold-standard assessment in our unit.  Indications for STARR were patients with ODS symptoms and/or symptomatic rectal anal intussusception (RAI) which impacted on their quality of life and in whom there are palpable, sigmoidoscopic and/or radiological evidence of high-grade RAI with or without a rectocoele [8].   We have also used STARR in a small group of patients with apparent anismus and RAI who have failed BFT.  STARR was performed as previously described [8] after a thorough EUA.

In patients with ODS an ODS score [13] was calculated (Table 1).  All patients had a Wexner FI [14] score calculated (Table 2).  The decision to treat, scoring and data collection were performed by the lead surgeon (ARD) in all patients.  Following surgery patients were followed up at 6 weeks (clinic), 6 months (clinic) and annually (by telephone if satisfied, otherwise in clinic) thereafter.  At follow-up attention was placed on recurrent symptoms, urgency and FI, and all patients were re-scored.  Symptom scores (ODS, FI) and patient satisfaction assessments were performed at every follow-up.  The last follow-up score was used in every patient, therefore the results refer to the median follow-up time of the group overall.

A prospective electronic, password-protected database collecting information on all 344 consecutive STARR procedures, including follow-up was used.  Retrospective statistical analyses were performed and graphs plotted using SPSS (v14.0, SPSS Inc, Illinois, USA).  Symptom-control (ODS) and symptom-decay (urgency) were analysed using Kaplan-Meier estimator plots to estimate symptom control and decay over time, and we statistically compared the Kaplan-Meier survival distribution of different patient groups using Mantel-Cox Log Rank tests.  Other data were compared using non-parametric Wilcoxon signed-rank tests.  A value of p<0.05 was considered significant.

 

 

Results

344 patients, median age 54 (19-90) (233 female, 68%) underwent STARR over the 9 years up to Jan 2010.  Follow-up data was available for 326 patients (95%).  Of the 326 patients with follow-up data, 249 were followed up beyond 52 weeks, and 149 beyond 104 weeks (43%).  The median follow-up was 98 weeks (CI 85 – 112).

Pre-operative symptoms included pelvic pain or discomfort in 321 (93%), incomplete emptying in 309 (90%), faecal urgency in 255 (74%), a sensation of obstruction in 222 (65%) and rectal digitation in 93 (27%).  13 patients had solitary rectal ulcer syndrome (SRUS).  Previous surgical interventions included: vaginal hysterectomy 54 (21%), abdominal hysterectomy 19 (8%), posterior repair for rectocoele 18 (8%) and laparoscopic ventral mesh rectopexy (VMR) 13 (4%).  278 patients reported rectal bleeding: 173 (50%) had undergone previous banding and 35 (10%) an excision haemorrhoidectomy within the previous 5-years.  EUA demonstrated a significant incidence of grade III/IV haemorrhoids, and high-grade RAI (Table 3).

Early complications:  The results are summarised in table 4. Although faecal impaction has not been reported in any other published studies, we found this to be a significant problem in 9 patients (2.6%). 

Obstructed Defaecation Scores:   The results are summarised in table 5.  Of the 235 patients in whom ODS scores were accurately recorded both pre- and postoperatively, 143 (61%) were asymptomatic at follow-up (ODS score 14.2 pre), 91 (39%) had improved symptoms (ODS score 16.3 pre, 4.6 post) and in one the ODS score was the same.  No patient recorded an increase in ODS scores.

Faecal Incontinence:  The results are summarised in table 6.  In the 4 patients in whom FI deteriorated, the increase in FI score was modest at a median of 1.5.  In the 23 in whom FI had improved but not completely gone, the score improved from 7.3 pre-operatively to 3.4 post-operatively. 

Faecal Urgency:  At all follow-up assessments, all patients were specifically asked if they had faecal urgency and how long it had lasted.  This information and symptoms at last follow-up were analysed using Kaplan Meier survival analysis to plot symptom decay.  The resulting graph plots the censored probability of urgency at various time-points in the follow-up cycle.  At the point of analysis 17.6% of patients had urgency (variable follow-up).  At the earliest follow-up (8 weeks) 72% of patients reported urgency.  At 16 weeks faecal urgency was present in 20% of patients, and in 11.5% at 52 weeks.  The incidence slowly decreases over time thereafter and in the 29 patients with follow-up beyond 4 years no urgency was present (Figure 1).  Further analysis comparing the decay of urgency between different patient groups (Mantel-Cox Log Rank) by sex, age, pre-operative ODS symptoms, FI, previous surgery and SRUS could not demonstrate a significant difference.

Recurrent symptoms:  Patients reported individual symptoms and occasionally patients reported a recurrence of their preoperative ODS.  The overall reported symptom recurrence rate was 9.5% (31), of which 6% (16) were immediately post-operatively (in 326 patients with follow-up).  This excludes urgency.  Patients who had pelvic pain previously had a higher risk of getting recurrent pain, and patients with SRUS were significantly at risk of developing recurrent symptoms (6 of 13).  Recurrent ODS was recorded in 16 (4.9%) patients.  Except for SRUS and pelvic pain at presentation we could not identify specific risk factors for recurrence of ODS with this analysis.

Patient satisfaction at last follow-up:  The results are depicted in the graph (figure 2), sub-divided into the main symptomatic groups of interest.  Numerical data are also shown in figure 2.  Overall 81% were highly satisfied with the procedure and its final outcome, and would recommend STARR or have it again.  A further 9% said that they would probably recommend and/or undergo the procedure.  Prolonged faecal urgency was cited as the cause of dissatisfaction in half (16) of the remaining 10%, even when it had eventually resolved.  Other causes were FI, recurrent ODS and pelvic pain.

 

 

 

 

 

 

 

 

 

 

 

 

 

Discussion

Before the introduction of STARR, ODS was viewed [15] as a non-surgical entity to be treated by combinations of dietary modifications, laxatives, enemas and various BFT programmes and/or rectal irrigation.  Several factors lead to this historical and still widely held view of internal rectal prolapse (IRP) being a variant of normal [16].  A small but widely quoted proctography study in the 1980s suggested that 20% of asymptomatic normal volunteers had a high-grade RAI [17].  As a result, most surgeons do not regard IRP as a true pathological-anatomical entity that can be surgically corrected.  Recently there has been a radiological re-evaluation of IRP in asymptomatic volunteers.  Dvorkin et al [18] demonstrated that IRP is morphologically more advanced in symptomatic patients, with significantly more full-thickness IRP and RAI rather than mucosal, shallower rectal-rectal intussusceptions in asymptomatic individuals.  Symptomatic RAI is therefore a significantly different entity in affected individuals compared to asymptomatic incidental RAI.

The poor functional results of using a traditional posterior rectopexy for correcting IRP have also not supported surgical treatment options [15].  Posterior rectal mobilisation leads to autonomic rectal denervation and the development of a hindgut neuropathy [19]; worse or new-onset obstructed defaecation is then seen in about 50% of patients [15].  Unsurprisingly, posterior rectopexy for IRP, by inducing the same neural lesion, results in a worsening of ODS symptoms that were the indication for surgery and, quite rightly, posterior rectopexy became discredited as a method of treating IRP [15].  None of the older established, yet intrinsically flawed operations addressed the anatomical and fascial abnormalities that are commonly encountered in patients with prolapse i.e., ventral support of the rectum, stabilisation of the cervix/vault or dealt with the distal rectal redundancy in the same way that Lap VMR [20, 21, 22] or STARR [2,8,9] does.  For those patients with high take-off grades IV/V RAI [23] and the 40-50% of patients who have coexisting anterior and middle compartment prolapse, we offer laparoscopic ventral mesh rectopexy and vaginal sacrocolpopexy (Lap VMR) ± laparoscopic anterior colporraphy ± TVT [20].  This most certainly contributes to the patients in this report representing a highly selective group when compared with other publications.

 

Despite the ongoing debate about the significance of IRP, FI improves post rectopexy.  Lazorthes et al [24] found IRP in 27% of patients with idiopathic FI that had been referred for proctography.  Lap VMR for rectal prolapse improves FI in about 90% [20, 21, 22] and more reliably than that seen with obstructed defaecation (80%).  The improvement in FI in our study supports the proposed role of IRP in the multi-factorial aetiology of FI. 

New onset FI is always a risk and concern following any trans-anal surgery.  A change in continence is, however, difficult to assess objectively following STARR as it is a frequent component of the presenting ODS symptom complex.  Our study reiterates the improvement in FI following STARR for ODS as reported by Jayne [9] and previously reported in a smaller cohort of patients [8].  The 3.2% incidence of new-onset FI in this series (based on scoring system) compares favourably to other studies [2], but of a notably moderate score (+2.9 median, range 0-7). 

FI probably most significantly affects quality of life, and is a crucial marker of success (or failure) of treatment, as suggested by the poor patient satisfaction data in the (persistent or new) FI patient group (Figure 2).  The third of FI patients who were still satisfied with the procedure reflects the improved FI scores despite incomplete resolution of all FI symptoms in those patients.

Faecal urgency, like FI, is a component of the ODS symptom complex which makes the interpretation of post-operative urgency difficult in some studies.  It has been widely appreciated that defaecatory urgency is common after STARR, and that it improves in many patients over time, but interestingly it has not really been reported accurately.  It is the fear of inducing urgency that has perhaps limited a wider uptake of STARR by UK surgeons.  The European Registry [9] has reported one of the highest rates of urgency, of 37.1% at 6 months and 26% at 12 months; Boccasanta [2] on the other hand reported an incidence of 1.1% at 12 months.  Using the data we collected over time, we constructed a statistically censored symptom decay graph over time using Kaplan Meier analysis.  This graph has enabled us to more clearly “predict” the probability of postoperative faecal urgency following STARR, and warn patients that 70% will have urgency in the first 8 weeks, up to 20% at 16 weeks and 11.5% at one year.  Long-term follow-up should demonstrate what occurs beyond 75 weeks of median follow-up where the incidence of urgency stands at 5%.  None of the 29 patients who have a follow-up beyond 4 years report any continued urgency.  We appear to be unable to predict who will develop this symptom that does not correlate with patient age, sex, hysterectomy, preoperative urgency or faecal incontinence (Mantel-Cox Log Rank test).

The aetiology of early postoperative urgency may well be inflammatory change within the mesorectum and/or staple-line, but this does not explain the persistent nature when other symptoms have resolved over many months.  The urgency is characterised by frequency of loose watery stool first thing in the morning and tends to follow breakfast only to settle by late morning; in general it has been our experience that loperamide has little if any effect. Whether this is a neuro-endocrine enteric motility response, possibly Gastrin mediated is not known, but we have seen patients respond to oral Ranitidine, Baclofen and Sacral Nerve Stimulation.  Further study is required to try to identify the underlying mechanisms and tailor treatment.  The importance of addressing postoperative urgency following STARR is evident from the poor patient satisfaction in this group of patients at long-term follow-up (Figure 2).

Symptom control is again surprisingly poorly reported on, possibly because the short follow-up in most series negates the usefulness at the time of reporting.  However, symptom-control is the key measurement of success once morbidity and side effects have been overcome.  We elected to report on individual symptoms since ODS is not a defined entity, but consists of a series of symptoms each of variable intensity.  We found that 4.9% of our patients have symptoms that constitute true ODS recurrence (symptoms the same or similar to pre-operatively).  An additional 4.2% have other symptoms, the most common symptom recurring (or not disappearing) being pelvic pain/discomfort.  SRUS patients were particularly susceptible to recurrent symptoms, a group in whom pain features highly.  On separate group analysis, patients who have pain pre-operatively (without SRUS) are most likely to report recurrent symptoms post-operatively.  We have demonstrated more success in SRUS patients with Lap VMR [20] and this is now becoming our default treatment option.

Treatment success for ODS overall is however very good and in keeping with previous published results [2-9].  The significant improvement in ODS scores is remarkable, and careful analysis of the results confirms that no patient had worsening of symptoms, all bar one had improvement despite the 4.9% recurrence rate which is included in these figures (the recurrences therefore had a lower ODS score than pre-STARR).  This overall benefit questions BFT as sole treatment [25].  However, we do carefully select patients, offer BFT where appropriate and also offer Lap VMR where we feel STARR may not address the contributing anatomical defects.

Recurrent symptoms should be regarded with a degree of suspicion.  Recurrent symptoms in one patient post STARR identified a new recto-sigmoid carcinoma (normal sigmoidoscopy 27 months earlier).  Two patients with recurrent symptoms have developed complications of sigmoid diverticular disease requiring resection.  One patient with persistent urgency and a staple-line ‘stenosis’, was found at laparoscopy to have extensive endometriosis involving the rectosigmoid.

Our study includes a significant number of male patients.  IRP is less well appreciated and poorly understood in male patients.  To date, only a limited number of males with ODS symptoms have been treated by STARR and entered into the European Registry [9].  It is our experience that ODS is a component in the symptom complex of many male patients presenting with persistent or recurrent grade 4 haemorrhoids, pelvic pain, chronic fissures etc.  The history almost always includes ‘constipation’ as a predominant feature.  Defaecatory proctography in such patients may demonstrate anatomical abnormalities commonly seen in females with ODS including pseudo-rectocoeles, enteroceles and IRP; many show pseudo-anismus.  Laparoscopy and EUA provides a clue as to a possible aetiology: a failure of Denonvillier’s fascia to fuse between prostate and rectum and a gynaecoid pelvis with a wide pelvic floor.  Whilst the anatomy of the standard male pelvis dictates that on average, the degree of apparent RAI is likely to be less than the female, the true extent of the RAI is sometimes not fully appreciated until after the posterior firing of the PPH STARR.  We suspect that other pelvic floor units will find more male patients coming through as it becomes apparent that pelvic floor dysfunction is not a sole female entity.

In conclusion, STARR has proved itself to be a successful treatment option for highly selected patients with ODS and IRP.  STARR has significant early morbidity, which is mostly manageable as an outpatient.  Faecal urgency is common but rapidly decreases over time to about 11% at 52 weeks and continues to decrease thereafter.  FI improves in almost all patients.  81% of patients expresses satisfaction with the procedure and would recommend it.  Recurrent ODS symptoms (4.9%), faecal incontinence symptoms and urgency are the most common reasons for dissatisfaction.

 

 

Frequency of defaecation

1 – 2 defaecations every 1 – 2 days

0

2 defaecations per week or 3 defaecations / attempts per day

1

1 defaecation per week or 4 defaecations / attempts per day

2

<1 defaecations per week or >4 defaecations / attempts per day

3

Intensity of straining

No or light

0

Moderate

1

Intense

2

Duration of straining

Short

1

Prolonged / repeated attempts

2

Incomplete evacuation

Never

0

<1 per week

1

2 per week

 

2

>2 per week

3

Rectoperineal discomfort

Never

0

<1 per week

1

2 per week

2

>2 per week

3

Reduction of activities

None

0

<25%

2

25-50%

4

>50%

6

Laxative use

None

0

<25% of defaecations

1

25-50% of defaecations

3

>50% of defaecations

5

Always

7

Enemas

Never

0

<25% of defaecations

1

25-50% of defaecations

3

>50% of defaecations

5

Always

7

Digitation

 

Never

0

<25% of defaecations

1

25-50% of defaecations

3

>50% of defaecations

5

Always

7

Table 1:  ODS Score [13] - cumulative score of defaecation habits

 

Type

Never

Rarely

<1/month

Sometimes

<1/week

Usually

<1/day

Always

Daily

Solid

0

1

2

3

4

Liquid

0

1

2

3

4

Gas

0

1

2

3

4

Pad

0

1

2

3

4

Lifestyle alteration

0

1

2

3

4

Table 2:  Wexner Faecal Incontinence Score [14] – cumulative score (0 – 20)

 

Internal rectal prolapse grade

N

1

0

2

5

3

98

4

205

5

36

Total

344

Table 3: Oxford grading of recto-anal intussusception [23].

 

 

 

 

 

 

 

 

 

 

 

 

Operative

Rectovaginal septum haematoma

1

 

Retention of urine

3

 

Rectal split

2

 

Staple failure

3

 

Transfusion

1

 

Mesenteric haematoma

1

 

Total operative

11

Post-operative

Haemorrhage

34 (10%)

 

-       Return to theatre

-       Ward

-       On / Off

-       Secondary (home)

-       Secondary (theatre)

8 (2.6%)

3

11

11

1

 

Faecal impaction

9 (2.6%)

 

Staple stricture

10 (2.9%)

 

Other

5

 

Total postoperative

58

TOTAL

69 early complications in 56 patients : 16.3%

Table 4:  Early complications following STARR in 344 patients

 

 

ODS Score pre-op (n = 256)

ODS Score post-op (n = 287)

Low (0-5)

20

260 (90%)

Moderate (6-10)

27

18

High (11+)

209 (81%)

9

Median

14.6 ± 5.4 (0 – 30)

1.6 ± 3.1 (0-18)

Statistical difference

*p<0.0001 Wilcoxon Signed Ranks Test

Table 5: Summary of effect of STARR on ODS scores

 

 

Wexner FI Score

Pre-op (342)

Post-op (326)

0

118

284

1-5

134

36

>5

90

6

Median

3.5 ± 3.3

0.4 ± 1.3

Statistical difference

*p<0.0001 Wilcoxon Signed Ranks Test

Table 6:  Summary of effect of STARR on Wexner FI scores

 

 

Figure 1:  Kaplan Meier Survival Analysis depicting urgency symptom decay over time

 

Figure 2:  Graphic illustration of patient satisfaction.  Graph proportional to total number in every group (percentage).


References:

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  12. Arroyo A, Gonzalez-Argente FX, Garcia-Domingo M, Espin-Basany E, De-la-Protilla F, Perez-Vicente F, Calpena R.  Prospective multicentre clinical trial of stapled transanal rectal resection for obstructive defaecation syndrome. BJS, 2008 95(12):1521-7
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  19. Speakman CT, Madden MV, Nicholls RJ, Kamm MA. Lateral ligament division during rectopexy causes constipation but prevents recurrence: results of a prospective randomized study. Br J Surg, 1991, 78(12):1431-3.
  20. Slawik S, Soulsby R, Carter H, Payne H, Dixon AR.  Laparoscopic ventral rectopexy, posterior colporrhaphy and vaginal sacrocolpopexy for the treatment of recto-genital prolapse and mechanical outlet obstruction.  Colorectal Dis. Feb 2008, 10(2): 138-43.
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  25. Rao SS.  Dyssenergic defecation and biofeedback therapy.  Gastroenterol Clin North Am 2008 Sep;37(3):569-86, viii.

 

 

 

Acknowledgement.  We should like to thank the following Laparoscopic/Pelvic floor fellows who have contributed to this study T Gill, S Pandy, F Court, S Slawik, R Soulsby, K Cross, N Kenerfic, A Menom, SM Phillips, L Titu, K Riyad, N Zafar, W Chambers and to the support of Mr Paul Durdey, Consultant Surgeon BRI


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