Stapled trans-anal rectal resection (STARR) for the surgical treatment of obstructed defecation syndrome associated with rectocele and rectal intussusception

Stapled  trans-anal rectal resection (STARR)

for the surgical treatment of obstructed defecation syndrome associated with rectocele and rectal intussusception

Hesham M  Hasan,a MD; Hani M Hasan,b MD

a) Department of General surgery, Ain Shams University, Cairo, Egypt.

b) Department of Obstetrics and Gynecology, AL-Azhar University, Cairo, Egypt.

Abstract

Obstructed  defecation  syndrome  (ODS)  is one of the most widespread  clinical  problems which frequently affect middle - aged females. There is a new surgical technique called stapled trans-anal rectal resection, (STARR) which makes it possible to remove the anorectal mucosa circumferential and reinforce the anterior anorectal  junction wall with the use of a circular stapler. This surgical  technique  developed  by Antonio Longo, was proposed  as an effective alternative for the treatment of ODS. In this study we present our preliminary results with the STARR operation for the treatment of ODS. For this purpose, 40 consecutive female patients with  ODS due to rectal  intussusception (RI)  and/or  rectocele (RE),were recruited  in this prospective clinical study, from May 2008 to October 2010. No major operative or postoperative complications were recorded, and after 12-months follow-up, significant improvement in the ODS score system was observed. The symptoms of constipation improved  in 90% of patients,

20% of patients judged their final clinical outcome as excellent, 55% as good, 15% as moderate, with only 10% having poor results. After analyzing our results we can conclude that STARR is an effective and safe procedure for the treatment of obstructed defecation syndrome due to rectal intussusception and/or  rectocele, and  can be performed  safely  without  major  morbidity.

Key words: Obstructed  defecation  syndrome, stapled transanal rectal resection  (STARR), rectocele, rectal intussusceptions.

Introduction:

Obstructed defecation syndrome (ODS) is a frequently occurring condition which usually affect middle - aged females. This disease can affect the quality of life of many patients, as these patients are obliged to spend several hours a day in the toilet; other symptoms of this disease include feeling of incomplete evacuation, excessive straining during defecation, the need for digital vaginal or perineal assistance and the use of enemas or suppositories  to defecate.IThe etiology of ODS may be functional disorders, secondary to a spastic pelvic floor syndrome, in which failure to relax, or paradoxical contraction of the anal sphincters muscles  can  causes the symptoms of ODS or anatomical rectal anomalies as rectal intussusception (RI) and/or rectocele (RE).2 By using anal 3-dimensional ultrasonography (3-DAUS), Regadas et a1.,3 demonstrated  that    the   anal   canal is

asymmetrical and that the internal anal sphincter is shorter in women, it is formed distally in the anterior upper anal canal weakening the anorectal junction which is devoid of striated muscle or any other anatomic support structure.4 Thus, herniation starts in the anterior upper anal canal and anorectal junction wall as demonstrated by echodefecography and anal 3-dimensional ultrasonography (3-DAUS) technique, suggesting that these patients have anorectocele rather than rectocele.5

Conservative therapy is considered the first line of treatment inpatients with ODS as more than 30% of   these patients showed  an improvement with diet and biofeedback therapy. Also this line of management  can avoid unnecessary and potentially dangerous surgery. Surgery should be reserved for patient with  structural abnormalities who  fail  to respond to conservative treatment.6 Patients

who do not respond to conservative treatment are usually multiparous females affected by a combination of intussusception and rectocele. In these patients the correction of rectocele with a vaginal or perineallevatorplasty is often ineffective.6,7

Stapled mucosectomy for treatment of rectal mucosa prolapse and hemorrhoids was initially described in 1997,8 and many publications have mentioned satisfactory  results.9,10,11,12

Recently, a new technique named stapled trans­

anal rectal resection; (STARR) developed by Antonio Longo has been described to treat the anorectal dysfunction such as rectocele  and rectal intussusceptions.13,14 STARR involves a double stapling technique with the use of a circular stapler to remove the anorectal mucosa circumferential and  reinforce the  anterior anorectal junction wall correcting the structural abnormalities associated with  ODS. Many publications demonstrated safety and efficacy of this procedure for the treatment of ODS and the published results  reported  symptomatic improvement among those patients_15,16

In this study we present our preliminary results  with  the  STARR  operation for the treatment of obstructive defecation syndrome due to RI and RE.

Patients and methods:

From  May  2008  to  October 2010, 40 consecutive female patients with ODS caused by RE and/or RI were  recruited in this prospective clinical study which was performed at AL-Jedaani hospital and Ibn Sena Medical College, Jeddah, Saudi Arabia.

All patients gave their written  informed consent  before  participating in this  study. Inclusion criteria:

-Patients with  symptoms of obstructed defecation due structural abnormalities (rectocele and /or rectal intussusceptions) who failed to respond to conservative measures in the form of diet therapy,  laxatives, enemas and/or physiotherapy for more than six months and at least a score of 12 on obstructed defecation syndrome score (ODS-S) Table(l).

-All the patients with an ODS-S  12 with RI  (intussusceptions  10 mm)  and/or  RE (extending 2 em or more from the rectal wall contour) shown by defecography Figure(l).

The presence of hemorrhoids was not a contraindication for inclusion  in the study. Exclusion criteria:

These included patients with good response

to  conservative treatment, slow  transit constipation, severe fecal  incontinence, enterocele  (grade 3, 4, and 5), and complete rectal prolapse of more than 3 em. Also patients with cystocele were excluded.

Preoperative clinical  evaluation  included complete history  of presenting symptoms, numbers of pregnancies, history of episiotomy, and previous pelvic or anal surgeries. Clinical examination of the perineum, rectum, and vagina was done to diagnose  any associated diseases. Proctoscopy was performed for all patients to exclude any associated  anorectal diseases.

Preoperative preparation  included  one or

two enemas at the morning of surgery, routine deep vein  thrombosis prophylaxis and perioperative broad  spectrum antibiotics. General or spinal anaesthesia was used based on the individual anesthetist preference. Two circular  PPH-01TM staplers (Ethicon Endo­ Surgery, Inc., USA) were used.  The patient was placed in the lithotomy position. An initial examination was undertaken to confirm  the presence and  extent  of  the  internal rectal prolapse and rectocele and also to confirm the absence of co-existent pathology Figure(2). Circular anal dilator was inserted into the anal canal and maintained secured to the perianal skin  with  two  stay  sutures (anterior and posterior). The rectocele was pushed through the anal canal with a finger inserted  into the vagina to identify its apex; the posterior vaginal wall was pulled up with a Babcock forceps, the apex  of the rectocele was pulled  down Figure(3). Three semi-circumferential purse­ string sutures were positioned in the anterior rectum at approximately 1, 2, and 3 em above the haemorrhoidal apex. The first PPH-01TM stapler was inserted and the posterior rectal wall was protected with a spatula.The ends of sutures were delivered through  the specific holes of the stapler, and tension was applied to prolapse the removed tissues into the stapler housing, making sure that the posterior vaginal wall had not been incorporated, the stapler was closed and fired. By the same procedure, two

semi-circumferential purse-string sutures and a second PPH-01™stapler were performed on  the  posterior rectal wall  Figure(4), Figure(S). Hemostatic stitches with  full­ thickness 2-0 Vicryl™ stitches were used to control bleeding fromstaples line.All surgical specimens obtained from procedure were sent for histological examination.

All patients had detaileddata on preoperative status, perioperative and  postoperative complications. A clinical  assessment  was performed at baseline and at 3, 6, and 12 months after surgery. The magnitude and degree of ODS were quantifiedby constipation

scoring system (CSS)_l7 The validated CSS consists of five items and the overall score ranges from  0 (normal) to 20 (severe constipation).The index of patient satisfaction was evaluated by a visual analog scale (VAS: with a score from 0 to 10), and a higher score suggests an improvement inpatient satisfaction after the surgery.

Statistical analysis was performed using paired t test for continuous  variables,  and Wilcoxon's signed-rank test for quantitative variables. A P value< 0.05 was considered statistically significant.

Table (1): Obstructed defecation syndrome score.

Never: 0 (never); rarely: <]/month,· Sometimes: <]/week, ?::}/month; Usually: <1/day, ?::1/week; Always: ?::1/day

Figure (1): Cystocolpodefecography in sitting position during straining; the  posterior colpocele

is caused by a significant rectocoele.

Figure (2): Anterior rectocele.                      Figure (3): Apex of the rectocele was pulled down.

Figure(4):Threesemi-circumferential purse-stringsutures.

Results:

During the period between May 2008 to

October 2010 there were 40 female patients with ODS caused by RE and/or RI (median

age, 45.7±12.3 years; range, 30-63 years) subjected to trans-anal rectal resection using PPH-01TM staplers (Ethicon Endo­ Surgery,Inc.,USA) were included in this prospective study. All had been followed up for 12 months after surgery.

An anterior rectocele was present in 36 patients (90%) and 22 patients (55%) bad an internal rectal prolapse and/or rectal mucosal prolapse. 32 patients (80%) had experienced

1-6 vaginal deliveries, 12 patients (30%) had experienced at least one episiotomy, and 18

patients (45%) bad undergone prior anorectal or gynecologic surgeries. All patients had symptoms of obstructed defecation syndrome Table(2).

The median operative time was 35±10 minutes, and the median hospital stay was

1.7±2.3  (ranging  from 1 to 5) days, the specimen dimensions were 6.8±2.5x9.7±1.9 em (height x width); rectal smooth muscle fibers were found in all the specimens. The only intraoperative complication was bleeding

from the anastomotic ring, which occurred in

800/o of cases and was secured with hemostatic stitches. The most common morbidity after surgery was defecatory  urgency, and the

incidence was 40% during the first postoperative week and decrease to 10% after

Figure(5):PPH-01™stapler.

threemonths follow up.Post operative bleeding occurred in4 (10%) patients, but it was minor and stopped spontaneously with conservative trea1ment with no further surgical intervention required. Other recorded complications were incontinence to flatus in2 (5%) patients, acute urinary retention in 2 (5%) patients, persistent post operative pain in 4 (10%) patients and anal fissure in one (2.5%) patient. No staple line dehiscence, massive rectal hemorrhage, rectovaginal fistula and perianal sepsis occurred, also, there were no postoperative mortality recorded Table(3). At 12 months follow-up, the symptoms of constipation improved in 36 (90%) patients however, constipation persists or recurred in 4 patients after STARR procedure.   There were a significant reduction in ODS scores at 12 months follow up as compared with baseline Table(4,5).

Postoperative cinedefecography showed residual anorectoceles (grade 1-U) in 6 (15%)

patients and residual second degree rectocele with internal mucosal prolapsed in 3 (7.5%) patients.   As compared to preoperative defecographic findings, anterior rectocele was significantly reduced from 90% to 15% of patients (P < 0.001).

After 12 months follow up eight patients (20%) judged their final clinical outcome as excellent, 22 patients (55%) as good, 6 patients (15%) as moderate, with only four patients (10%)   having   poor  results Table(6).

Table (3): Postoperative complications.

Table (4): Preoperative obstructed defecation  syndrome score of the 40 patients.

Tabk (5): The obstructed defecation syndrome score before and at 12 months after the stllpling procedure.

P < 0.001= highly  significant.

Discussion:

ODS is a challenging clinical problemthe pathophysiology of which remains not clearly

defined RE and RIhoweverare the two most frequent anatomic defects associated with ODS. Although various surgical procedures have been  described for  the  treatment of  the syndromemany of these are unsuitable for patients accompanied with RE and RI.ls Until the development of the STARR technique there was no surgical procedure for correction of ODSand patients were treated conservatively with diet and biofeedback therapy.In contrast to the transvaginal approach  and perineal levatorplasty used to treat rectocele, the STARR procedure corrects both rectocele and rectal intussusception.19 Traditional operations in patients with both rectal mucosal prolapse and rectocele are associated with a high incidence of delayed healing of the perineal wound and dyspareunia. The combined endo-anal  and perineal approach increased the risk of sepsis due to fecal contamination and led to potentially fatal cases of pelvic gangrene.19

STARR  has  been  demonstrated as an alternative  operation  and a relatively non invasive surgical technique for ODS caused by RE and RI. The novel procedure aims to correct rectocele,  resect  internal prolapse, restore anatomy, correct rectal volume, and improve  function.20 But   it   has   been demonstrated that patient selection should be very  careful because only  symptomatic rectocele or rectal intussusception& justifies surgical treatmenother associated pathologies such as irritable colon or pudendal neuropathy are not modified by operation so symptoms may persist.21 A multicentric study done by Stuto  et ai.,22 demonstrated that  STARR procedure, for  management of  ODS,  is technically simple to perform and able to revert all constipation symptoms; the operative time

and hospital stay were shortthe postoperative pain and bleeding were minimalthere were no sepsis or postoperative dyspareuniaand patients return early to work. Several studies confirm the safety and efficacy of the STARR procedure for management ofODS.23-25 Also the data collected from this prospective clinical study suggest  thatmore  than 90% of our patients had satisfactory surgical results with improved  symptoms of ODS with STARR procedure, coupled with few intraoperative and postoperative  complications. The only intraoperative incident was bleeding from the staple line which occurred in 80% of patients so the anastomotic ring should be meticulously checked and carefully secured with stitches whenever   necessary. The  most  common morbidity after surgery was defecatmy urgency and the incidence inour study was 40% during the first postoperative week and decreased to

10% after  three  months  follow  up. Other published studies have shown that defecatory urgency was the most common complaint in the immediate  and intermediate recovery periods after STARR.25,26 Although the exact etiology of defecatory urgency is unclearit may reflect the inflammatory response related to the staple line, presence of irritable rectum and reduced rectal capacity or compliance. No major complications such as massive rectal hemorrhage and anastomotic line dehiscence occurred in our study. Few studies reported the incidence of severe complications such as staple line dehiscencerectal diverticulum pelvic   infection and  even   fulminating necrotizing pelvic  fasciitis following the STARR procedure.27,28 Incontinence has been claimed to  be  a potential postoperative drawback of STARR, it may be a procedure­ related  complication caused  by transient sphincteric impairment during instrumentation and anal dilatation.29-31 In this studyonly two

(5%) patients complained of incontinence to flatus during the first two weeks after the procedures and improved within 3 months of surgery. Our results confirmed that the rate of postoperative pain was low, and there were no cases of dyspareunia. Also, Edward et al.,32 in their prospective study concluded that, STARR procedure is safe and effective, particularly in young females, due  to the absence of complications related to  the  perineal levatorplasty and better results on postoperative pain, absence of dyspareunia and better clinical outcome.  Frascio et aP3 in their  trial on 30 patients reported no mortality or pelvic sepsis and 4%  of post  operative bleeding treated surgically, while in our study Postoperative bleeding occurred in 4 (10%) patients, but it was minor  and stopped  spontaneously with conservative treatment with no further surgical intervention required.

It is reasonable to suggest  that the high percentage of successful results obtained, the short postoperative length of stay and the short time to return to work after STARR procedure for management of ODS would balance  the relatively high   cost   of  the   procedure.

Conclusion:

Obstructed defecation syndrome (ODS) is one of the most widespread clinical problems which frequently affect middle-aged females. Rectocoele (RE) and rectal intussusception (RI) are the two most common anatomic defects associated  with ODS. STARR  represents a true revolution in the surgical  treatment of ODS caused by (RE)  and/or (RI)  and it appeared to be  safe  and  effective with  a successful outcome  in most of the patients. Longer follow up period more than 12 months may be needed to assess long term functional outcomes and  symptomatic recurrence.

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